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Reduced-Intensity Regimen Before Allogeneic Bone Marrow Transplantation in Treating Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00057954   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2003   Last Updated: April 14, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

April 7, 2003
April 14, 2009
June 2005
Engraftment [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00057954 on ClinicalTrials.gov Archive Site
 
 
 
Reduced-Intensity Regimen Before Allogeneic Bone Marrow Transplantation in Treating Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma

RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet light and drugs outside the body to inactivate T cells.

Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation.

PURPOSE: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkin's or Hodgkin's lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) bone marrow transplantation.
  • Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
  • Determine the 100-day overall survival and long-term progression-free survival of patients treated with this regimen.
  • Evaluate the feasibility of collection of molecular chimerism studies at baseline, days 30, 100, 6 months and one and two years and at relapse.

OUTLINE: This is a multicenter study.

  • Conditioning regimen: Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4.

Patients receive pentostatin IV continuously on days -3 to -2 and undergo total body irradiation on day -1.

  • Allogeneic bone marrow transplantation: Patients undergo infusion of allogeneic bone marrow or stem cells on day 0.
  • Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation, oral mycofenolate mofetil beginning on day 100 and continuing for 1 year, and methotrexate IV on days 1 and 3.

Patients are followed at day 100, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 1.8 years.

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Drug: cyclosporine
  • Drug: methotrexate
  • Drug: methoxsalen
  • Drug: mycophenolate mofetil
  • Drug: pentostatin
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
36
 
October 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of non-Hodgkin's or Hodgkin's lymphoma

    • Relapsed disease following a course of high-dose chemotherapy or autologous stem cell transplantation
  • Availability of 1 of the following bone marrow donors:

    • 5/6 or 6/6 HLA-matched related donor (sibling, parent, or child)
    • 10/10 matched unrelated donor by molecular typing at HLA A, B, C, D, DR
    • No umbilical cord blood donors NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.

However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • AST and ALT less than 3 times upper limit of normal (ULN)
  • Bilirubin less than 3 times ULN

Renal

  • Creatinine clearance greater than 50 mL/min

Cardiovascular

  • LVEF at least 45% by MUGA or echocardiogram

Pulmonary

  • DLCO at least 50% of predicted
  • FEV_1 at least 50% of predicted

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Physically and psychologically capable of undergoing bone marrow transplantation and its attendant period of strict isolation
  • HIV negative
  • Able to receive total body irradiation of 400 cGy
  • No evidence of active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 90 days since prior autologous stem cell transplantation

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 2 weeks since prior parenteral antibiotics
Both
18 Years and older
No
 
United States
 
 
NCT00057954
Robert L. Comis, ECOG Group Chair's Office
ECOG-1402
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Francine M. Foss, MD Yale University
Investigator: Kenneth B. Miller, MD Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
October 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.