Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00574496
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • cyclophosphamide — DRUG
  • cyclosporine — DRUG
  • fludarabine phosphate — DRUG
  • gemcitabine hydrochloride — DRUG
  • ifosfamide — DRUG
  • mechlorethamine hydrochloride — DRUG
  • melphalan — DRUG
  • methotrexate — DRUG
  • mycophenolate mofetil — DRUG
  • prednisone — DRUG
  • procarbazine hydrochloride — DRUG
  • vincristine sulfate — DRUG
  • vinorelbine tartrate — DRUG
  • allogeneic bone marrow transplantation — PROCEDURE
  • allogeneic hematopoietic stem cell transplantation — PROCEDURE
  • nonmyeloablative allogeneic hematopoietic stem cell transplantation — PROCEDURE
  • peripheral blood stem cell transplantation — PROCEDURE
  • umbilical cord blood transplantation — PROCEDURE
  • total-body irradiation — RADIATION

Study Details

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, mycophenolate mofetil, and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy followed by donor stem cell transplant works in treating patients with relapsed or high-risk primary refractory Hodgkin lymphoma.

Key Dates

Start date
Nov 13, 2007
Status verified
Oct 2022
Primary completion
Aug 2, 2022
Completion
Aug 2, 2022

Study Design

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

Arms

  • Experimental: High-Risk or Relapsed Hodgkin Lymphoma
    This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.

Primary Outcome Measure

Progression-free Survival at 1 Year [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

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By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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