Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation for Hematologic Cancer or Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Closed 50 and under Other MSGCC-9720 NCI-V98-1428

Objectives

I.  Evaluate a T-cell depletion technique known to prevent graft-versus-host 
disease in patients with leukemia, lymphoma, myelodysplastic syndromes, 
multiple myeloma, or metastatic breast cancer who receive a bone marrow 
transplant (BMT) from a matched unrelated donor or a single DR/DW antigen 
mismatched related or unrelated donor.

II.  Evaluate the incidence and quality of engraftment and completeness of 
chimerism in this patient population.

III.  Determine the incidence of relapse after BMT according to stage of 
disease at the time of BMT.

IV.  Determine the toxicity of the regimen and the incidence and type of 
complications after BMT.

V.  Determine the feasibility of unrelated and mismatched transplants in 
patients over 40 years old.

Entry Criteria

Disease Characteristics:

Biopsy confirmed:
  - Acute myelogenous leukemia or acute lymphocytic leukemia in first or
     subsequent remission or in relapse with a low tumor load
  - Chronic myelogenous leukemia
  - Myelodysplastic syndrome
  - Aggressive or refractory Hodgkin's disease or non-Hodgkin's lymphoma
  - Multiple myeloma after early relapse or chemotherapy to reduce tumor
     burden
  - High risk chronic lymphocytic leukemia
  - Aplastic anemia
  - Metastatic breast cancer

No complete response to standard chemotherapy

No evidence of active extramedullary disease

Hormone receptor status:
 Not specified

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Age:
 50 and under

Menopausal status:
 Not specified

Performance status:
 Karnofsky 70-100%

Life expectancy:
 Greater than 8 weeks

Hematopoietic:
 Not specified

Hepatic:
 Bilirubin less than 2 mg/dL and not increasing for 2-4 weeks prior to
  transplant
 SGOT no greater than 4 times upper limit of normal and not increasing
  for 2-4 weeks prior to transplant

Renal:
 Creatinine less than 2 times normal and not rising for 2-4 weeks prior to
  transplant OR
 Creatinine clearance greater than 60 mL/min

Cardiovascular:
 LVEF greater than 50% by MUGA

Pulmonary:
 DLCO greater than 50% of predicted

Other:
 Not HIV positive
 Not pregnant or nursing
 Fertile patients must use effective contraception during and for 1 year
  following transplant

Expected Enrollment

A total of 14 to 24 patients will be accrued for this study over 2.5 years.

Outline

Prior to bone marrow transplantation, patients undergo a preparative 
cytoreduction regimen of total body irradiation and chemotherapy.  Patients 
undergo TBI on days -10 to -7.  TBI is administered 3 times per day every 4-6 
hours on days -10 to -8, then 2 fractions on day -7.  Male patients with acute 
lymphocytic leukemia receive an additional dose of radiation to the testicles, 
and patients with myelodysplastic syndromes receive an additional dose of 
radiation to the spleen during TBI.  Thiotepa is administered IV over 4 hours 
on days -5 and -4.  Cyclophosphamide is administered IV over 1 hour on days -3 
and -2.

Patients receive an allogeneic bone marrow transplant on day 0.  Bone marrow 
is harvested from the donor, and depleted of T-cells by differential 
agglutination with soybean lectin followed by rosetting with sheep red blood 
cells.  The T-cell depleted bone marrow is infused over 15 minutes to the 
patient.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Guido Tricot, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 410-328-1230; 800-888-8823 Email: gtricot@umcc01.umcc.ab.umd.edu