Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00946023
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Days -6 through -2: 30 mg/m\^2 IV daily
  • Cyclophosphamide — DRUG
    Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
  • Total body irradiation — RADIATION
    Day -1: 200 centigray (cGy) in a single fraction
  • Tacrolimus — DRUG
    Start on Day 5 through Day 180
  • Mycophenolate Mofetil — DRUG
    Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
  • Rituximab — DRUG
    Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
  • Allogeneic Bone Marrow Transplant (BMT) — BIOLOGICAL
    Day 0: Donor bone marrow infusion

Study Details

This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation and rituximab works in treating patients with B-cell lymphoma or chronic lymphocytic leukemia who are undergoing an allogeneic (donor) bone marrow transplant. The type of bone marrow transplant is a less intensive or "mini" transplant using a relative as the bone marrow donor. The donated bone marrow stem cells may replace the patient's immune system cells and help destroy any remaining cancer (graft-versus-tumor effect). Patients undergoing this type of transplant often have more than one relative who could be a donor. The trial is also studying a new way of choosing amongst possible donors which might improve how the rituximab works.

Key Dates

Start date
Jul 31, 2009
Status verified
Jul 2018
Primary completion
Jul 31, 2013
Completion
Jul 17, 2013

Study Design

Enrollment
135 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transplant
    Non-myeloablative allogeneic bone marrow transplant (BMT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD (graft vs host disease) prophylaxis. Rituximab will be given as post-transplant maintenance.

Primary Outcome Measure

Progression-free Survival [ Time Frame: 1 year post-intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-

Find similar trials in Baltimore, MD

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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