Stem Cell Transplant for Patients With Blood Malignancy Using Donors and Less Toxic Chemotherapy With CAMPATH 1H

Sponsor

Baylor College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00048412

Collaborator

The Methodist Hospital Research Institute (Other), Center for Cell and Gene Therapy, Baylor College of Medicine (Other)

Enrollment

Locations

53.4

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the treatment related mortality of allogeneic stem cell transplantation with non-myeloablative therapy incorporating the lymphodepleting MAb CAMPATH-1H, in patients with hematological diseases and renal cell carcinoma not eligible for conventional (myeloablative) therapy.
To assess the time to engraftment and incidence of graft failure in patients receiving this transplant regimen.
To assess the safety, pharmacokinetics and immunologic activity of CAMPATH-1H when used as part of a subablative conditioning regimen.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Disorders Leukemia Multiple Myeloma Plasma Cell Dyscrasia Lymphoproliferative Disorders	Drug: FLUDARABINE Drug: CAMPATH 1H Drug: FK50 Procedure: Stem Cell Collection and Infusion	Phase 1/Phase 2

Detailed Description

This is a two arm study in which outcomes will be assessed independently in recipients of HLA matched sibling transplants and recipients of unrelated or mismatched family donor transplants, although both groups will receive identical treatments.

The following will be given to the patient after admission:

Day - 6: Total body irradiation

Day - 5 to - 2: Fludarabine and Campath 1H

Day - 1: Day of rest

Day 0: Stem cell transplant (infusion)

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

Nov 12, 2004

Actual Study Completion Date :

Nov 12, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia and Hodgkins Disease) or Renal Cell Carcinoma.
Conditions that increase treatment related mortality (need one or more to be eligible):
Greater to or equal to 50 years of age.
EF of less than 45%
DLCO less than 50% of FEV1 50-75% of predicted value.
Diabetes Mellitus
Renal Insufficiency (but creatine clearance not less than 25ml/min).
Prior recent history of systemic fungal infection.
3rd or greater remission of AML or ALL
More than 1 year of diagnosis (CML or Myeloma patients)
Multiple types of treatment regimens. (equal to or more than 3)
Prior autologous or allogeneic stem cell transplantation.
Significant grade III or IV neurologic or hepatic toxicity from previous treatment.
No matched sibling donor.
Available healthy donor without any contraindications for donation. 5/6 or 6/6 related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1)
Patient and/or responsible person able to understand consent.
Age between birth and 70 years.
For women of childbearing potential, negative pregnancy test.

Exclusion criteria

Patient is pregnant, lactating or unwilling to use contraceptives
HIV positive patient
Uncontrolled intercurrent infection
Refractory AML, or ALL
Untreated Blast Crisis for CML
Uncontrolled High-grade lymphoproliferative disease/lymphoma.
Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
Hemodialysis dependent
Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal.
Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)
Active CNS disease from hematological disorder.