Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Northside Hospital, Inc.
Study ID
NCT00818961
Phase
PHASE2
Status
Terminated

Conditions

  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases

Eligibility Criteria

Sex
ALL
Age
40 Years - 72 Years
Healthy Volunteers
Not accepted

Interventions

  • alemtuzumab — BIOLOGICAL
    43 mg subcutaneously over 3 days (3 mg on day -11, 10 mg on day -10, 30 mg on day -9)
  • graft-versus-tumor induction therapy — BIOLOGICAL
    curative potential of allogeneic transplant results from the immune anti-tumor effect of donor cells or GVT/GVL
  • rituximab — BIOLOGICAL
    in patients with Cd20+ malignancies: rituximab 375 mg/m\*2 day -13. rituximab 1000 mg/m\*2 on days, -6, +1, +8.
  • busulfan — DRUG
    For patients with AML, CML, MDS, MPS and ALL only: IV or oral busulfan may be given IV busulfan: 130 mg/m2 over 3 hours once daily on days -6, -5, -4 and -3 Oral busulfan: taken every 6 hours x 15 doses beginning on day -7 at 6pm and continuing through day -3 at 6am. 1 mg/kg test dose will be given prior to day -7 and PK samples will be drawn to calculate AUC.
  • cyclophosphamide — DRUG
    750 mg/m2 infused over 1 hour once daily on days -5, -4 and -3. Cyclophosphamide will be started approximately 4 hours after the start of Fludarabine
  • fludarabine phosphate — DRUG
    For patients with CLL, NHL \& HD: 30 mg/m2 infused over 30 minutes once daily on days -5, -4 and -3 For patients with AML, CML, MDS, MPS and ALL: 40 mg/m2 infused over 30 minutes once daily on days -6, -5, -4 and -3.
  • methotrexate — DRUG
    5 mg/m2 administered on days +1, +3 and +6
  • tacrolimus — DRUG
    0.03mg/kg/day infused over 24 hours starting on day -1 and switched to oral (twice daily divided dose) on day 14 or when able to tolerate PO
  • allogeneic bone marrow transplantation — PROCEDURE
    Recipients will receive an allogeneic transplant on day 0 after receiving high-dose chemotherapy. This trial uses matched unrelated donor stem cells.

Study Details

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and to see how well it works in treating patients with high-risk hematologic cancer.

Key Dates

Start date
May 31, 2005
Status verified
Oct 2013
Primary completion
Mar 31, 2011
Completion
Mar 31, 2012

Study Design

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

Arms

  • Other: Hematopoietic Stem Cell Transplantation
    All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on donor type

Primary Outcome Measure

Survival at Day 100 [ Time Frame: 100 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
Blood and Marrow Transplant Group of GeorgiaAtlantaGeorgia30342-

Find similar trials in Atlanta, GA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Blood and Marrow Transplant Group of Georgia· Atlanta, GA

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