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Phase 2 N=76 Treatment

Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma

Prolymphocytic Leukemia · Recurrent Adult Hodgkin Lymphoma · Recurrent Childhood Hodgkin Lymphoma · Recurrent Childhood Non-Hodgkin Lymphoma · Recurrent Chronic Lymphocytic Leukemia

Enrolled (actual)
76
Serious AEs
13.2%
Results posted
Dec 2017
Primary outcome: Primary: Engraftment of HLA Identical PBSC Allografts — 53 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Autologous Hematopoietic Stem Cell Transplantation (Procedure); Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation (Procedure); Carmustine (Drug); Cyclophosphamide (Drug); Cyclosporine (Drug); Cytarabine (Drug); Etoposide (Drug); Fludarabine Phosphate (Drug); Laboratory Biomarker Analysis (Other); Melphalan (Drug); Mycophenolate Mofetil (Drug); Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (Procedure); Peripheral Blood Stem Cell Transplantation (Procedure); Therapeutic Autologous Lymphocytes (Biological); Total-Body Irradiation (Radiation)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Fred Hutchinson Cancer Center
Primary completion
Jan 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Engraftment of HLA Identical PBSC Allografts
53
PRIMARY
Non-Relapse Mortality
3
SECONDARY
Overall Survival (OS)
39; 14; 1; 31; 10; 0
SECONDARY
Progression Free-survival (PFS)
36; 12; 1; 27; 8; 0

Summary

This phase I/II trial studies how well autologous stem cell transplant followed by donor stem cell transplant works in treating patients with lymphoma that has returned or does not respond to treatment. 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. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

Eligibility Criteria

Inclusion Criteria

  • Patients with lymphoma (non-Hodgkin lymphoma [NHL], chronic lymphocytic leukemia/small lymphocytic lymphoma [CLL/SLL] or Hodgkin's lymphoma) with primary refractory or relapsed disease after standard chemotherapy at high risk of relapse with conventional autografting; patients with a diagnosis of CLL (or small lymphocytic lymphoma) or diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL
  • 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 granulocyte-colony stimulating factor (G-CSF) (filgrastim) administration and leukapheresis for both PBSC allograft and subsequent donor lymphocyte infusion (DLI)
  • DONOR: Must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian)
  • DONOR: Age 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 peripheral blood mononuclear cells (PBMC) only will be permitted as a hematopoietic stem cell (HSC) source on this protocol

Exclusion Criteria

  • 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 serum glutamic oxaloacetic transaminase [SGOT] or serum glutamate pyruvate transaminase [SGPT] > 2 x normal); patients may be accepted outside of this range if cleared by gastrointestinal (GI) consult
  • Cardiac ejection fraction (EF) 50 years or there is a history of anthracyclines or history of cardiac disease; patients with a shortening fraction 2.0 mg/dl and a calculated or measured creatinine clearance of 20% risk of disease recurrence; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy
  • DONOR: Identical twin
  • DONOR: Age less than 12 years
  • DONOR: Pregnancy
  • DONOR: Human immunodeficiency virus (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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00005803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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