Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: B-Cell Prolymphocytic Leukemia, Hypodiploidy, Loss of Chromosome 17p, Plasma Cell Leukemia, Progression of Multiple Myeloma or Plasma Cell Leukemia, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Non-Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Recurrent Childhood Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Small Lymphocytic Lymphoma, t(14;16), t(4;14), T-Cell Prolymphocytic Leukemia, Waldenstrom Macroglobulinemia

In brief

This phase II trial studies autologous peripheral blood stem cell transplant followed by donor bone marrow transplant in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia. Autologous stem cell transplantation uses the patient's stem cells and does not cause graft versus host disease (GVHD) and has a very low risk of death, while minimizing the number of cancer cells. Peripheral blood stem cell (PBSC) transplant uses stem cells from the patient or a donor and may be able to replace immune cells that were destroyed by chemotherapy. These donated stem cells may help destroy cancer cells. Bone marrow transplant known as a nonmyeloablative transplant uses stem cells from a haploidentical family donor. Autologous peripheral blood stem cell transplant followed by donor bone marrow transplant may work better in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic lymphocytic leukemia.

Key facts

Study ID: NCT01008462
Run by: Fred Hutchinson Cancer Center
People needed: 16
Starts: 2010-03-18
Expected to finish: 2018-06-30
Last updated by the study team: 2019-06-11

Who can join

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

You may qualify if…

Must have the capacity to give informed consent
Detectable tumor prior to mobilization regimen
Patients with stored autologous stem cells will be allowed
Stem cells from an identical donor could be used for autologous hematopoietic cell transplant (HCT)
Marrow is the preferred source of stem cells from the HLA-haploidentical donor, however, peripheral blood mononuclear cells (PBMC) could be used as stem cell source, after clearance with the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator, in the case of difficulties or contraindications to bone marrow harvest from the donor
Cross-over to other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) 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
Cross-over from other tandem autologous-allogeneic research protocol (#1409 or other appropriate protocol) 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
Lymphoma: patients with
Diagnosis of non-Hodgkin lymphoma (NHL) or Hodgkin's lymphoma (HL), of any histological grade
Refractory or relapsed disease after standard chemotherapy
High risk of early relapse following autograft alone
Waldenstrom's macroglobulinemia: must have failed 2 courses of therapy
CLL:
Patients with either a:
Diagnosis of T-cell CLL or T-cell prolymphocytic leukemia (PLL) who have failed initial chemotherapy, patients with T cell CLL or PLL or
Diagnosis of B-cell CLL, B-cell small lymphocytic lymphoma, or B-cell CLL that progressed to PLL who either:
Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. 2-chlorodeoxyadenosine [CDA], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog)
Failed any aggressive chemotherapy regimen, such as fludarabine, cyclophosphamide and rituximab (FCR), at any time point
Have "17p deletion" cytogenetic abnormality and relapsed at any time point after initial chemotherapy
Harvesting criteria for autologous HCT:
Previously collected PBMC may be used
Circulating CLL cells < 5000
Marrow involvement with CLL cells < 50%
Multiple myeloma (MM): patients who
Have received induction therapy for a minimum of 4 cycles

You may not qualify if…

Life expectancy severely limited by disease other than malignancy
Seropositive for the human immunodeficiency virus
Female patients who are pregnant or breastfeeding
Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy
Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years
This exclusion does not apply to patients with non-hematologic malignancies that do not require therapy
Patients with fungal infection and radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
Symptomatic coronary artery disease or ejection fraction < 40% or other cardiac failure requiring therapy (or, if unable to obtain ejection fraction, shortening fraction of < 26%); ejection fraction is required if the patient has a history of anthracyclines or history of cardiac disease; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist
Corrected diffusion capacity of the lungs for carbon monoxide (DLCO) < 50% of predicted, forced expiratory volume in one second (FEV1) < 50% of predicted, and/or receiving supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study must approve of enrollment of all patients with pulmonary nodules
Patient with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; the patient will be excluded if he/she is found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease
Karnofsky score < 50% for adult patients
Lansky play-performance score < 40 for pediatric patients
Patient with poorly controlled hypertension despite multiple antihypertensives
DONOR: Donor-recipient pairs in which the HLA-mismatch is only in the host-versus-graft (HVG) direction
DONOR: Infection with human immunodeficiency virus (HIV)
DONOR: Weight < 20 kg
DONOR: A positive anti-donor cytotoxic crossmatch

Where it is running

Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.