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Bone Marrow Transplant

Autologous Stem Cell Transplant Followed By Donor Stem Cell Transplant In Treating Patients With Relapsed or Refractory Lymphoma (FH 1409)
A Phase I/II Study of Autologous Stem Cell Transplantation Followed by Non-Myeloablative Allogeneic Stem Cell Transplantation for Patients with Relapsed or Refractory Lymphoma - A Multi-Center Trial
Status Conditions Phase Study ID
Recruiting Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Phase I/II FH 1409
NCT00005803
Summary

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase I/II trial is studying how well giving autologous stem cell transplant followed by donor stem cell transplant works in treating patients with relapsed or refractory lymphoma.


Investigator
David Maloney, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with lymphoma (NHL or Hodgkin Disease) with primary refractory or relapsed disease after standard chemotherapy at high risk of relapse with conventional autografting
  • Must have an HLA genotypically or phenotypically identical related donor or, at a minimum, a high likelihood of identifying an HLA-matched unrelated donor; the determination of availability of a suitable unrelated donor may be based on a World-Book search
  • Cross-over to other tandem autologous-allogeneic research protocol (#2241) will be allowed if the patient loses the suitable HLA-matched related or unrelated donor but has an available HLA-haploidentical donor before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
  • Cross-over from other tandem autologous-allogeneic research protocol (#2241) will be allowed if a suitable HLA-matched related or unrelated donor is identified before receiving the allogeneic transplantation and if the patient meets the eligibility criteria of the subsequent study
  • Signed informed consent
  • Detectable tumor on radiographic studies or bone marrow biopsy prior to mobilization regimen
  • Expected survival >= 3 months from study entry
  • DONOR: HLA genotypically or phenotypically identical related donor
  • DONOR: must consent to G-CSF administration and leukapheresis for both PBSC allograft and subsequent DLI
  • DONOR: must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian)
  • DONOR: Age < 75 yrs, older donors may be considered after review at Patient Care Conference
  • DONOR: FHCRC matching allowed will be Grades 1.0 to 2.1; unrelated donors who are prospectively: Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
  • DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
  • DONOR: patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
  • DONOR: Only G-CSF mobilized PBMC only will be permitted as a HSC source on this protocol
Exclusions (conditions that would prevent participation in this study)
  • Life expectancy severely limited by disease other than lymphoma
  • Prior autologous hematopoietic stem cell transplant
  • Patients at high risk of veno-occlusive disease of the liver (criteria not yet rigorously defined but includes bilirubin > 2.0 mg and SGOT or SGPT > 2 x normal); patients may be accepted outside of this range if cleared by GI consult
  • Cardiac EF < 40% on MUGA scan or cardiac echo; patients with active or a history of cardiac disease should be evaluated with appropriate cardiac studies and/or consult; ejection fraction is required if age > 50 years or there is a history of anthracyclines or history of cardiac disease
  • Baseline serum-creatinine > 2.0 mg/dl and a calculated or measured creatinine clearance of < 50 ml/minute
  • Seropositive for the human immunodeficiency virus (HIV)
  • Pulmonary dysfunction as measured by a corrected DLCO < 50% of predicted TLC < 30%, FEV1 < 30% and/or receiving supplementary continuous oxygen
  • Pregnancy or breast-feeding
  • Radiation therapy to mediastinum within 3 months prior to enrollment
  • Patients with poorly controlled hypertension despite hypertensive medication
  • Karnofsky score < 60; pediatric criteria: Lansky Play-Performance Score < 40
  • Patients with CD34 selected auto grafts
  • Patients with active non-hematologic malignancies (except nonmelanoma skin cancers)
  • Patients with a history of non-hematologic malignancies (except nonmelanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence
  • DONOR: Identical twin
  • DONOR: Age less than 12 years
  • DONOR: Pregnancy
  • DONOR: HIV seropositivity
  • DONOR: Inability to achieve adequate venous access
  • DONOR: Known allergy to G-CSF
  • DONOR: Current serious systemic illness
  • DONOR: Failure to meet FHCRC criteria for stem cell donation
  • DONOR: Donor (or centers) who will exclusively donate marrow
Last Updated
November 07, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.