Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT00002809

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Biological: anti-thymocyte globulin Biological: filgrastim Biological: sargramostim Biological: therapeutic immune globulin Drug: cyclophosphamide Drug: methotrexate Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Study the curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow from volunteer HLA-matched donors in patients with a variety of hematologic malignancies and bone marrow failure states.
Study the toxic effects associated with matched unrelated bone marrow transplantation in this patient population.
Participate in collaborative research studies with the National Marrow Donor Program.

OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case of graft failure.

All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus, methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as necessary, antithymocyte globulin.

Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States

Study Start Date :

Aug 1, 1996

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

One of the following hematologic malignancies/disorders:
Acute lymphoblastic leukemia
In second or subsequent complete remission (CR)
In first CR with high-risk features (e.g., Philadelphia chromosome-positive)
In first relapse and failed conventional salvage therapy
Acute myelogenous leukemia (AML)
In second or subsequent CR
In early first relapse
In full first relapse and failed conventional salvage therapy
In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7
Standard-risk AML offered conventional-dose consolidation chemotherapy or autologous bone marrow transplantation
Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase
No blast crisis
Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy
Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated intravascular coagulation, thrombotic events)
Myelodysplastic syndrome, i.e.:
Symptomatic, transfusion-dependent refractory anemia with excess blasts
(RAEB) or RAEB in transformation
Secondary leukemia in CR following conventional-dose induction chemotherapy
Unrelated marrow donor available who is 8 out of 10-, 9 out of 10-, or 10 out of 10-antigen serologically HLA-matched at A, B, C, DRb, and DQB loci by molecular typing
No CNS malignancy