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

Completed · Phase 1/Phase 2

Conditions studied: Prolymphocytic Leukemia, Recurrent Adult Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Recurrent Childhood Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Small Lymphocytic Lymphoma, T-Cell Chronic Lymphocytic Leukemia, T-Cell Prolymphocytic Leukemia

In brief

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).

Key facts

Study ID: NCT00005803
Run by: Fred Hutchinson Cancer Center
People needed: 76
Starts: 1999-09-01
Expected to finish: 2018-10-01
Last updated by the study team: 2020-01-29

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 < 75 years (yrs), older donors may be considered after review at Patient Care Conference
DONOR: Fred Hutchinson Cancer Research Center (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 peripheral blood mononuclear cells (PBMC) only will be permitted as a hematopoietic stem cell (HSC) source on this protocol

You may not qualify if…

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) < 40% on multi-gated acquisition (MUGA) scan or cardiac echocardiogram (echo) (or if unable to obtain ejection fraction, shortening fraction of < 26%); 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; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist
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 diffusing capacity of the lung for carbon monoxide (DLCO) < 50% of predicted total lung capacity (TLC) < 30%, forced expiratory volume in 1 second (FEV1) < 30% and/or receiving supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study must approve enrollment of all patients with pulmonary nodules
Pregnancy or breast-feeding
Patients with poorly controlled hypertension despite hypertensive medication
Karnofsky score less than 60; pediatric criteria: Lansky Play-Performance Score < 40
Patients with cluster of differentiation (CD)34 selected auto grafts
Patients with active non-hematologic malignancies (except non-melanoma skin cancers); this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy
Patients with a history of non-hematologic malignancies (except non-melanoma 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; 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

Where it is running

Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
LDS Hospital — Salt Lake City, Utah, United States
VA Puget Sound Health Care System — Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
Universitaet Leipzig — Leipzig, Germany

Full record on ClinicalTrials.gov

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