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Sequential Myeloablative Stem Cell Transplantation and Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma and Hodgkin's Disease


Phase 1/Phase 2
N/A
30 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Hodgkins Disease

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Trial Information

Sequential Myeloablative Stem Cell Transplantation and Reduced Intensity Allogeneic Stem Cell Transplantation in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma and Hodgkin's Disease


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To study the feasibility of administering sequential myeloablative APBSCT followed by reduced intensity Allo SCT in patients with refractory/recurrent NHL and HD.

Outcome Time Frame:

Until end of study

Safety Issue:

No

Principal Investigator

Prakash Satwani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAA5185

NCT ID:

NCT00802113

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkins Disease
  • Autologous Stem Cell Transplant
  • Cord Blood Transplant
  • Allogeneic Stem Cell Transplant
  • Relapsed Lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Columbia University Medical CenterNew York, New York  10032