Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00705250
• Collaborator: Cephalon (Industry)
• Enrollment: 36
• Location: 1
• Arm: 1
• Duration (Months): 90
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The standard treatment for patients with HL that has not responded to treatment or has come back after treatment is stem cell transplant. When patients are not eligible for transplant or when HL comes back after transplant, there are no standard treatment options. These patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a chemotherapy agent that is effective in treating patients with various diseases, including non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for the treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern Europe have shown that bendamustine HCl is likely effective for treating HL. This study will find out the effect of bendamustine HCl for transplant-ineligible patients with HL that has not responded to or has come back after treatment.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Disease; Lymphoma	Drug: bendamustine hcl	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma.
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 bendamustine hcl 120mg/m^2	Drug: bendamustine hcl; Patients will receive bendamustine 120mg/m^2, administered as a 30-minute infusion, for two consecutive days. Cycles will be repeated every four weeks and a total of 6 cycles will be planned. Patients will receive pegfilgrastim with each cycle. Treatment will be delayed until the absolute neutrophil count is > 1000/ul and the platelet count is > 75,000/ul.

Outcome Measures

Primary Outcome Measures

1. Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL. [up to 3 years]

   The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologic diagnosis of Classical Hodgkin lymphoma, confirmed by the department of hematopathology at MSKCC. Patients who have relapsed after an autologous stem cell transplant must have a biopsy after transplant to confirm relapsed Hodgkin's disease. Patients who have relapsed after an allogeneic transplant must also have a biopsy posttransplant.

• Age > or = to 18

• All patients must have PET avid measurable disease.

• Last chemotherapy > or = to 4 weeks from the start of Bendamustine HCl

• Receiving no other treatment for HL

• Patients must have normal baseline cardiac function based upon echocardiogram or gated blood pool scan (MUGA) with an ejection fraction > or = to 50%

• Patients must have a serum creatinine of < or = to 1.5 mg/dl; if creatinine >1.5 mg/dl creatinine clearance must be >60 ml/minute.

• Patients must have ANC>1000/mcl and Platelets>100,000/mcl.

• Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).

• Patients must be Hepatitis B surface antigen and Hepatitis B core antibody negative and Hepatitis C negative.

• Patients must have failed an autologous stem cell transplant or be ineligible for an autologous stem cell transplant due to chemo-refractory disease(as defined as <50% response to standard salvage chemotherapy).

• Women who are pre-menopausal must have a negative pregnancy test

• Subjects must agree to use appropriate contraception until 4 weeks after the completion of chemotherapy.

• Patients must be HIV negative.

• If patients have a history of malignancy other than cutaneous basal cell or squamous cell carcinoma, they must be disease-free for ≥ 5 years at the time of enrollment.

• Patients or their guardians must be capable of providing informed consent.

Exclusion Criteria:

• Patients with either parenchymal brain or lepto-meningeal involvement.

• 7 or more consecutive days of prednisone therapy prior to therapy.

• Known pregnancy or breast-feeding.

• Medical illness unrelated to HL, which in the opinion of the attending physician and principal investigator will preclude administration of chemotherapy safely. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis

• History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix.

• Relapse <6 months post allogeneic stem cell transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• Cephalon

Investigators

• Principal Investigator: Craig Moskowitz, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00705250
• Other Study ID Numbers: 08-041
• First Posted: Jun 26, 2008
• Last Update Posted: Mar 3, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Memorial Sloan Kettering Cancer Center: Bendamustine HCL
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Bendamustine Hydrochloride

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
Period Title: Overall Study
STARTED	36
COMPLETED	34
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description
Overall Participants	36
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	34
Sex: Female, Male (Count of Participants)
Female	23 63.9%
Male	13 36.1%

Outcome Measures

1. Primary Outcome

Title	Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.
Description	The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.
Time Frame	up to 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description
Measure Participants	34
Number [percentage of evaluable participants]	56 155.6%

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	5/36 (13.9%)
Blood and lymphatic system disorders
Self-limited Gross Hematuria	1/36 (2.8%)
Gastrointestinal disorders
Vomiting	1/36 (2.8%)
General disorders
Febrile neutropenia	2/36 (5.6%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/36 (2.8%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	36/36 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	18/36 (50%)
Anemia	5/36 (13.9%)
Neutropenia	3/36 (8.3%)
Gastrointestinal disorders
Nausea	18/36 (50%)
Vomiting	8/36 (22.2%)
Constipation	3/36 (8.3%)
Mucositis	2/36 (5.6%)
General disorders
Fatigue	30/36 (83.3%)
Fever	4/36 (11.1%)
Pneumonia	4/36 (11.1%)
Febrile Neutropenia	2/36 (5.6%)
Hematuria	2/36 (5.6%)
Respiratory, thoracic and mediastinal disorders
Cough	8/36 (22.2%)
Dyspnea	7/36 (19.4%)
Respiratory Infection	3/36 (8.3%)

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.