Autologous and Allogeneic Transplant for Relapsed Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Hodgkins Disease

In brief

The sequential combination of myeloablative therapy and autologous stem cell transplantation (APBSCT) followed by a reduced intensity allogeneic stem cell transplant (Allo SCT) and post SCT adoptive cellular immunotherapy will be well tolerated in patients with refractory or recurrent non-Hodgkin's lymphoma (NHL) and Hodgkin's disease (HD).

Key facts

Study ID

NCT00802113

Run by

Columbia University

People needed

30

Starts

2003-06-01

Expected to finish

2014-10-22

Last updated by the study team

2019-03-27

Who can join

Age: any, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have adequate organ function as below
• Adequate renal function defined as:
• Serum creatinine less than or equal to 2.0 x normal, or
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
• Adequate liver function defined as:
• Total bilirubin <2.0 x normal; or
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) or serum glutamic-pyruvic transaminase (SPGT) (alanine aminotransferase (ALT)) <5.0 x normal
• Adequate cardiac function defined as:
• Shortening fraction of >27% by echocardiogram, or
• Ejection fraction of >47% by radionuclide angiogram or echocardiogram
• Adequate pulmonary function defined as:
• Diffusing capacity of the lungs for carbon monoxide (DLCO) >50% by pulmonary function test for autologous transplant
• DLCO > 40% by pulmonary function test for reduced intensity allogeneic transplant
• For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% in room air.
• Disease Status (Eligibility)
• Patients with Non-Hodgkin's Lymphoma with either of the following:
• Primary induction failure (failure to achieve initial CR) who have a partial response (PR) or stable disease (SD) with reinduction chemotherapy. *All patients are required to have a biopsy regardless of positron emission tomography (PET)/Gallium results.
• Patients with 1st PR, 2nd CR, 2nd PR, or 2nd SD following reinduction chemotherapy
• Patients with 3rd CR, 3rd PR, 3rd SD following reinduction chemotherapy
• Patients with Hodgkin's Disease with either of the following:
• Primary induction failure (failure to achieve initial CR) and/or primary refractory disease.
• First relapse
• Early relapse (within 12 months off therapy) (excluding those who received no therapy or radiation therapy only for initial therapy)
• Late relapse (greater than 12 months off therapy). Only patients with recurrent Stage III or IV disease and/or those with B symptoms at relapse (all other late relapses are excluded).
• Second relapse.

You may not qualify if…

• Patients with NHL or HD with 4th or greater CR, PR, and/or SD
• Patients with progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy
• Hodgkin's Disease in late relapse (other than those discussed above).
• Patients with post-transplant lymphoproliferative disease following a solid organ transplantation or AIDS associated NHL
• Patients who don't have an eligible donor
• Women who are pregnant

Where it is running

• Children's Memorial Hospital in Chicago — Chicago, Illinois, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University — Durham, North Carolina, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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