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Bone Marrow Transplant

Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients with High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia (FHCRC-2241)
Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients with High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
Status Conditions Phase Study ID
Recruiting Chronic Lymphoid Leukemia (CLL)
Hematologic Malignancies
Hodgkin's Lymphoma
Leukemia
Lymphoma
Multiple Myeloma (MM)
Non-Hodgkin's Lymphoma (NHL)
Phase II FHCRC-2241
NCT01008462
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 cancer cells. These donated stem cells may help destroy cancer cells (graft-versus-tumor effect).

PURPOSE: This study was designed to combine two types of stem cell transplant. The first would be the use of high-dose chemotherapy and autologous stem cell transplantation (using your own stem cells). This type of stem cell transplant has the advantage of no GVHD and very low risk of death, while minimizing the number of cancer cells. Then, the investigators will wait for a period between 40-120 days to allow your body to recover from the high-dose chemotherapy. Then, you will receive the second type of transplant "nonmyeloablative transplant" from your haploidentical family donor. The investigators hope that the donor cells will then eliminate any remaining tumor cells.

We are doing this study: -To see if the combined stem cell transplant will help prevent the blood or lymph nodes' cancer from coming back. -To see if the combined stem cell transplant will be safe with no increased toxicities or deaths compared to "nonmyeloablative transplant" alone.


Investigator
Mohamed Sorror, MD, MSc
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

  • Must have the capacity to give informed consent
  • Detectable tumor on radiographic studies or bone marrow biopsy prior to mobilization regimen
  • Patients who may have HLA-matched unrelated donor but the search could not be completed due to concerns of rapidly progressive disease could be eligible for this protocol
  • Patients with stored autologous stem cells will be allowed
  • Stem cells from an identical donor could be used for autologous HCT
  • Lymphoma: Patients with i) diagnosis of NHL or HL, of any histological grade; ii) refractory or relapsed disease after standard chemotherapy; iii) high risk of early relapse following autograft alone
  • Waldenstrom's Macroglobulinemia: must have failed 2 courses of therapy
  • CLL: Diagnosis of B-cell CLL, B-cell small lymphocytic lymphoma, or B-cell CLL that progressed to prolymphocytic leukemia (PLL) who either:
  • I) Failed to meet NCI Working Group criteria for complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. 2-CDA, pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog)
  • II) Failed any aggressive chemotherapy regimen, such as FCR, at any time point
  • III) Have "17p deletion" cytogenetic abnormality and relapsed at any time point after initial chemotherapy
  • CLL: Diagnosis of T-cell CLL or T-cell PLL who have failed initial chemotherapy
  • CLL: Harvesting criteria for autologous HCT: I) previously collected PBMC may be used; II) circulating CLL cells < 5000
  • CLL: Marrow involvement with CLL cells < 50%
  • MM: Have received induction therapy for a minimum of 4 cycles
  • MM: In addition, patients must meet at least one of the following criteria I-IX (I-VII at time of diagnosis or pre-autograft): I) any abnormal karyotype by metaphase analysis except for isolated t(11,14); II) FISH translocation 4:14; III) FISH translocation 14:16; IV) FISH deletion 17p; V) beta2-microglobulin > 5.5 mg/ml; VI) cytogenetic hypodiploidy
  • MM: VII) plasmablastic morphology (>= 2%); VIII) recurrent or non-responsive (less than PR) MM after at least two different lines of conventional chemotherapy; IX) progressive MM after a previous autograft (provided stored autologous CD34 cells are available)
  • Plasma cell leukemia: after induction chemotherapy
  • Donor Selection: Related donors who are genotypically identical for one HLA haplotype and who may be mismatched at the HLA-A, -B, -C or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or -C allele mismatches
Last Updated
October 25, 2011
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.