High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00536601
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 174
• Location: 1
• Arms: 7
• Actual Duration (Months): 144.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Nasal Type Extranodal NK/T-cell Lymphoma; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Myeloid Leukemia in Remission; Childhood Burkitt Lymphoma; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET); Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Peripheral T-cell Lymphoma; Plasma Cell Neoplasm; Primary Systemic Amyloidosis; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Neuroblastoma; Recurrent Small Lymphocytic Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Multiple Myeloma; Regional Neuroblastoma; Splenic Marginal Zone Lymphoma; Testicular Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia	Drug: etoposide; Drug: cyclophosphamide; Drug: carmustine; Drug: melphalan; Drug: busulfan; Drug: carboplatin; Drug: thiotepa; Radiation: total-body irradiation; Procedure: autologous hematopoietic stem cell transplantation; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose therapy regimen.

SECONDARY OBJECTIVES:

1. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors for each disease-specific high dose therapy regimen.

2. Explore the role of risk factors in the outcome of all treated patients. III. Examine the high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow transplant (BMT).

OUTLINE:

Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.

Study Design

• Study Type: Interventional
• Actual Enrollment: 174 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors
• Actual Study Start Date: Jun 29, 2006
• Actual Primary Completion Date: Jul 9, 2018
• Actual Study Completion Date: Jul 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen CBV (patients with HL or NHL) Patients receive etoposide intravenously (IV) continuously over 34 hours on day -8, cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours on day -3. Patients undergo ASCT on day 0.	Drug: etoposide; Given IV; Other Names: EPEG VP-16 VP-16-213 ; Drug: cyclophosphamide; Given IV; Other Names: CPM CTX Cytoxan Endoxan Endoxana ; Drug: carmustine; Given IV; Other Names: BCNU BiCNU bis-chloronitrosourea ; Procedure: autologous hematopoietic stem cell transplantation; Undergo ASCT
Experimental: Regimen M200/M120 (patients with MM or amyloidosis) Patients receive 200 or 120 mg/m^2 of melphalan IV over 30 minutes on day -2. Patients undergo ASCT on day 0.	Drug: melphalan; Given IV; Other Names: Alkeran CB-3025 L-PAM L-phenylalanine mustard L-Sarcolysin ; Procedure: autologous hematopoietic stem cell transplantation; Undergo ASCT
Experimental: Regimen BuC2iv (patients with ALL, AML, HL, or NHL) Patients receive busulfan IV over 2 hours then every 6 hours on days -7 to -4 for 16 total doses and cyclophosphamide IV over 2 hours on days -3 and -2. Patients undergo ASCT on day 0.	Drug: cyclophosphamide; Given IV; Other Names: CPM CTX Cytoxan Endoxan Endoxana ; Drug: busulfan; Given IV; Other Names: BSF BU Misulfan Mitosan Myeloleukon ; Procedure: autologous hematopoietic stem cell transplantation; Undergo ASCT
Experimental: Regimen CT6 (patients with ALL) Patients receive cyclophosphamide IV over 2 hours on days -5 to -4. Patients then undergo TBI twice daily on days -3 to -1. Patients undergo ASCT on day 0.	Drug: cyclophosphamide; Given IV; Other Names: CPM CTX Cytoxan Endoxan Endoxana ; Radiation: total-body irradiation; Undergo TBI; Other Names: TBI ; Procedure: autologous hematopoietic stem cell transplantation; Undergo ASCT
Experimental: Regimen CTtCp (patients with other solid tumors) Patients receive cyclophosphamide IV continuously, carboplatin IV continuously, and thiotepa IV continuously over 24 hours on days -7 to -4. Patients undergo ASCT on day 0.	Drug: cyclophosphamide; Given IV; Other Names: CPM CTX Cytoxan Endoxan Endoxana ; Drug: carboplatin; Given IV; Other Names: Carboplat CBDCA JM-8 Paraplat Paraplatin ; Drug: thiotepa; Given IV; Other Names: Oncotiotepa STEPA TESPA Tespamin TSPA ; Procedure: autologous hematopoietic stem cell transplantation; Undergo ASCT
Experimental: Regimen VCp (patients with testicular cancer) Patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Patients then undergo a second ASCT on day 0.	Drug: etoposide; Given IV; Other Names: EPEG VP-16 VP-16-213 ; Drug: carboplatin; Given IV; Other Names: Carboplat CBDCA JM-8 Paraplat Paraplatin ; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation; Undergo tandem ASCT
Experimental: Regimen TtC1500/ECpM (patients with NBL or SRBCT) Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 2 hours on days -5 to -2. Patients undergo ASCT on day 0. At least 4 weeks after the first transplant, patients receive carboplatin IV continuously over 24 hours on days -7 to -4, etoposide IV continuously over 24 hours on days -7 to -4, and melphalan IV over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0.	Drug: etoposide; Given IV; Other Names: EPEG VP-16 VP-16-213 ; Drug: cyclophosphamide; Given IV; Other Names: CPM CTX Cytoxan Endoxan Endoxana ; Drug: melphalan; Given IV; Other Names: Alkeran CB-3025 L-PAM L-phenylalanine mustard L-Sarcolysin ; Drug: carboplatin; Given IV; Other Names: Carboplat CBDCA JM-8 Paraplat Paraplatin ; Drug: thiotepa; Given IV; Other Names: Oncotiotepa STEPA TESPA Tespamin TSPA ; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation; Undergo tandem ASCT

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) [From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years]

   Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.

Secondary Outcome Measures

1. Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) [Up to 100 days after transplantation]

   Toxicities will be reported using descriptive statistics.

2. Response Rate (Complete Remission) [At 100 days]

   Response rates will be reported using descriptive statistics.

3. Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) [Patients are followed up to maximum of 12 years]

   Assessed using the product-limit based Kaplan Meier method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy

• Recurrent or refractory disease or disease at high risk for recurrence

• Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen

• Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score

• Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits

• Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits

• Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression

• Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy

• Amyloidosis: primary or previously treated

• Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity

• Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor; a syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient

• Performance status 0-2 (Karnofsky performance status [KPS] >= 70%); patients with amyloidosis or MM with decreased KPS due to disease are eligible

• Life expectancy > 2 months

• Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or diffusing volume of the alveolar volume (DLVA) >= 50% predicted; DLCO to be corrected for hemoglobin and/or alveolar ventilation

• Cardiac ventricular ejection fraction >= 50% by radionuclide ventriculogram or echocardiogram

• Bilirubin < 3 x normal

• Alkaline phosphatase, serum glutamic oxaloacetic transaminase (SGOT) < 3 x normal

• Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics

• Glomerular filtration rate by renal scan for neuroblastoma patients, to determine dosing parameters

• Positive cytomegalovirus (CMV) immunoglobulin M (IgM) and/or positive hepatitis serologies demonstrating infection will require an Infectious Disease consult and subsequent clearance

• Any active infection will require an Infectious Disease consult and subsequent clearance

• Peripheral Blood Counts of polymorphonuclear neutrophil (PMN) > 1500/uL

• Platelet (Plt) > 75,000/uL

• Prior to stem cell storage:

• No radiation within three weeks before stem cell harvest

• Bone marrow may be used in conjunction with blood progenitor cells

• Hematologic Malignancy patients with human immunodeficiency virus (HIV) positivity but on appropriate anti-retroviral therapy may go autotransplant with the following laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number < 100,000 per microliter and with Infectious Disease clearance

• Acute Leukemia, HL, NHL, MM and Solid Tumor patients must have received 2 cycles of chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells; small round blue cell tumor patients must have received either standard therapy or surgical intervention; the disease status and response to therapy must be known prior to transplant to establish the disease status at transplant; amyloidosis patients may proceed to BMT without receiving chemotherapy

• No serious organ dysfunction unless it is caused by the underlying disease, exclusion criteria include the following:

• Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, symptomatic angina, life-threatening arrhythmia or hypertension

• Active bacterial, viral, or fungal infection

• Active peptic ulcer disease

• Uncontrolled diabetes mellitus

• No serious medical or psychiatric illness

• Not pregnant

• No psychiatric conditions which would prevent delivery of care; psychology clearance is necessary

• Allogeneic BMT not possible, or not desirable

• Age > 65 years

• No compatible donor identified

• Estimated risk of graft vs. host disease complications greater than risk of recurrence after autologous BMT

• Adequate bone marrow or blood stem cell dose obtained:

• For blood stem cells: total CD 34+ >= 2 x 10^{6/kg or if unable to collect this dose, a total nucleated cell bone marrow dose of >= l x 10}8/kg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

• Roswell Park Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Philip McCarthy, Roswell Park Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 6, 2018

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT00536601
• Other Study ID Numbers: I 72806; NCI-2011-00131; I 72806; P30CA016056
• First Posted: Sep 28, 2007
• Last Update Posted: Apr 22, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Burkitt Lymphoma; Lymphoma; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Multiple Myeloma; Lymphoma, Follicular; Sarcoma; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large B-Cell, Diffuse; Neuroblastoma; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Lymphoma, T-Cell, Cutaneous; Waldenstrom Macroglobulinemia; Sarcoma, Ewing; Lymphoma, Large-Cell, Anaplastic; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Neoplasms, Plasma Cell; Plasmacytoma; Lymphomatoid Granulomatosis; Lymphoma, Extranodal NK-T-Cell; Testicular Neoplasms; Neuroectodermal Tumors, Primitive, Peripheral; Intraocular Lymphoma; Immunoglobulin Light-chain Amyloidosis; Amyloidosis; Recurrence; Cyclophosphamide; Melphalan; Busulfan; Thiotepa; Carmustine; Carboplatin; Etoposide; Etoposide phosphate

Study Results

Participant Flow

Arm/Group Title	Acute Leukemia	Hodgkin Lymphoma	Non-Hodgkin Lymphoma	MM/Amyloid	Solid Tumors
Arm/Group Description	Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia	Patients diagnosed with and treated for Hodgkin Lymphoma	Patients diagnosed with and treated for Non-Hodgkin Lymphoma	Patients diagnosed with or treated for multiple myeloma or amyloidosis	Patients diagnosed with and treated for a solid tumor
Period Title: Overall Study
STARTED	6	21	71	65	11
COMPLETED	6	21	71	65	11
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Acute Leukemia	Hodgkin Lymphoma	Non-Hodgkin Lymphoma	MM/Amyloid	Solid Tumors	Total
Arm/Group Description	Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia	Patients diagnosed with and treated for Hodgkin Lymphoma	Patients diagnosed with and treated for Non-Hodgkin Lymphoma	Patients diagnosed with or treated for multiple myeloma or amyloidosis	Patients diagnosed with and treated for a solid tumor	Total of all reporting groups
Overall Participants	6	21	71	65	11	174
Age, Customized (Count of Participants)
0-39 years	1 16.7%	8 38.1%	6 8.5%	3 4.6%	9 81.8%	27 15.5%
40-59 years	1 16.7%	7 33.3%	43 60.6%	26 40%	2 18.2%	79 45.4%
60-75 years	4 66.7%	6 28.6%	22 31%	36 55.4%	0 0%	68 39.1%
Sex: Female, Male (Count of Participants)
Female	5 83.3%	11 52.4%	23 32.4%	29 44.6%	3 27.3%	71 40.8%
Male	1 16.7%	10 47.6%	48 67.6%	36 55.4%	8 72.7%	103 59.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 4.8%	1 1.4%	0 0%	0 0%	2 1.1%
Not Hispanic or Latino	6 100%	20 95.2%	70 98.6%	65 100%	11 100%	172 98.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	2 33.3%	1 4.8%	3 4.2%	8 12.3%	1 9.1%	15 8.6%
White	4 66.7%	20 95.2%	68 95.8%	57 87.7%	10 90.9%	159 91.4%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	6 100%	21 100%	71 100%	65 100%	11 100%	174 100%
Risk Group (Count of Participants)
High	6 100%	10 47.6%	43 60.6%	10 15.4%	11 100%	80 46%
Standard	0 0%	11 52.4%	24 33.8%	44 67.7%	0 0%	79 45.4%
Unknown	0 0%	0 0%	4 5.6%	11 16.9%	0 0%	15 8.6%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
Description	Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
Time Frame	From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years

Outcome Measure Data

Analysis Population Description

Each disease strata presents PFS for each conditioning regimen defined in the protocol

Arm/Group Title	Acute Leukemia	Hodgkin Lymphoma	Non-Hodgkin Lymphoma	MM/Amyloid	Solid Tumors
Arm/Group Description	Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia	Patients diagnosed with and treated for Hodgkin Lymphoma	Patients diagnosed with and treated for Non-Hodgkin Lymphoma	Patients diagnosed with or treated for multiple myeloma or amyloidosis	Patients diagnosed with and treated for a solid tumor
Measure Participants	6	21	71	65	11
BuCy	33 550%	14 66.7%	22 31%
CBV	43 716.7%	37 176.2%
VCp	0 0%	43 204.8%
Mel120	22 366.7%
Mel200	13 216.7%
CyTtCp	0 0%
TtC1500	50 833.3%

2. Secondary Outcome

Title	Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))
Description	Toxicities will be reported using descriptive statistics.
Time Frame	Up to 100 days after transplantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Leukemia	Hodgkin Lymphoma	Non-Hodgkin Lymphoma	MM/Amyloid	Solid Tumors
Arm/Group Description	Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia	Patients diagnosed with and treated for Hodgkin Lymphoma	Patients diagnosed with and treated for Non-Hodgkin Lymphoma	Patients diagnosed with or treated for multiple myeloma or amyloidosis	Patients diagnosed with and treated for a solid tumor
Measure Participants	6	21	71	65	11
Count of Participants [Participants]	1 16.7%	9 42.9%	19 26.8%	31 47.7%	3 27.3%

3. Secondary Outcome

Title	Response Rate (Complete Remission)
Description	Response rates will be reported using descriptive statistics.
Time Frame	At 100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Leukemia	Hodgkin Lymphoma	Non-Hodgkin Lymphoma	MM/Amyloid	Solid Tumors
Arm/Group Description	Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia	Patients diagnosed with and treated for Hodgkin Lymphoma	Patients diagnosed with and treated for Non-Hodgkin Lymphoma	Patients diagnosed with or treated for multiple myeloma or amyloidosis	Patients diagnosed with and treated for a solid tumor
Measure Participants	6	21	71	65	11
Count of Participants [Participants]	5 83.3%	17 81%	54 76.1%	17 26.2%	7 63.6%

4. Secondary Outcome

Title	Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)
Description	Assessed using the product-limit based Kaplan Meier method.
Time Frame	Patients are followed up to maximum of 12 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Leukemia	Hodgkin Lymphoma	Non-Hodgkin Lymphoma	MM/Amyloid	Solid Tumors
Arm/Group Description	Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia	Patients diagnosed with and treated for Hodgkin Lymphoma	Patients diagnosed with and treated for Non-Hodgkin Lymphoma	Patients diagnosed with or treated for multiple myeloma or amyloidosis	Patients diagnosed with and treated for a solid tumor
Measure Participants	6	21	71	65	11
Number (95% Confidence Interval) [Proportion of participants]	33 550%	61 290.5%	45 63.4%	39 60%	46 418.2%

Adverse Events

Time Frame	SAE= 100 days after transplantation All cause mortality = 12 years
Adverse Event Reporting Description	SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
Arm/Group Title	Acute Leukemia		Hodgkin Lymphoma		Non-Hodgkin Lymphoma		MM/Amyloid		Solid Tumors
Arm/Group Description	Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia		Patients diagnosed with and treated for Hodgkin Lymphoma		Patients diagnosed with and treated for Non-Hodgkin Lymphoma		Patients diagnosed with or treated for multiple myeloma or amyloidosis		Patients diagnosed with and treated for a solid tumor
All Cause Mortality
	Acute Leukemia		Hodgkin Lymphoma		Non-Hodgkin Lymphoma		MM/Amyloid		Solid Tumors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/6 (66.7%)		8/21 (38.1%)		41/71 (57.7%)		45/65 (69.2%)		6/11 (54.5%)
Serious Adverse Events
	Acute Leukemia		Hodgkin Lymphoma		Non-Hodgkin Lymphoma		MM/Amyloid		Solid Tumors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		9/21 (42.9%)		19/71 (26.8%)		31/65 (47.7%)		3/11 (27.3%)
General disorders
Regimen Related Toxicity	1/6 (16.7%)	1	9/21 (42.9%)	9	19/71 (26.8%)	19	31/65 (47.7%)	31	3/11 (27.3%)	3
Other (Not Including Serious) Adverse Events
	Acute Leukemia		Hodgkin Lymphoma		Non-Hodgkin Lymphoma		MM/Amyloid		Solid Tumors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/21 (0%)		0/71 (0%)		0/65 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.