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Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	30 and under	Other	CHNY-01-501 AAAA5185, NCT00802113

Trial Description

Summary

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).

Eligibility Criteria

Inclusion Criteria:

• Patient must have adequate organ function as below

Adequate renal function defined as:

Serum creatinine 2.0 x normal, or Creatinine clearance or radioisotope 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 SGOT (AST) or SGPT (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:

DLCO >50% by pulmonary function test for autologous transplant DLCO > 40% by pulmonary fuction 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 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 intial 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. Third relapse.

• Patients must achieve a CR, PR or SD after reinduction chemotherapy.

Exclusion Criteria:

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Prakash Satwani, MD

Principal Investigator

Prakash Satwani, MD		Ph: 212-305-0223
		Email: ps2087@columbia.edu

Lauren Harrison, RN		Ph: 978-993-4372
		Email: la313@columbia.edu

U.S.A.
New York
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00802113
Information obtained from ClinicalTrials.gov on March 18, 2009