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A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin 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
intravenously (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.


Inclusion Criteria:



- Non-Hodgkin's or Hodgkin's lymphoma that has relapsed following either a course of
high dose chemotherapy or autologous stem cell transplantation.

- >= 90 days from prior transplant.

- Have a suitable human leukocyte antigen (HLA)-matched related bone marrow donor or a
compatible matched unrelated bone marrow donor by molecular typing at HLA A, B, C, D,
DR.

- Physically and psychologically capable of undergoing bone marrow transplantation and
its attendant period of strict isolation.

- Age >= 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Be able to receive 400 cGy Total Body Irradiation (TBI).

- Pulmonary function tests: Diffusing capacity or Transfer factor of the lung for
carbon monoxide (DLCO) >= 50% predicted, the forced expiratory volume in 1 second
(FEV1) >= 50% predicted.

- Left ventricular ejection fraction (LVEF) at least 45% by Multi Gated Acquisition
Scan (MUGA) or echocardiogram.

- Renal function: creatinine clearance > 50 ml/min.

- Liver function tests: < 3 x Upper Limit of Normal (ULN). Liver function test include
serum glutamic oxaloacetic transaminase (SGOT) (Aspartate transaminase (AST)), Serum
Glutamic Pyruvate Transaminase (SGPT) (Alanine transaminase (ALT)), and bilirubin.

Exclusion Criteria:

- Human immunodeficiency virus positive (HIV+) patients (test positive for P21
antibodies to HIV).

- Evidence of active infection (have received parenteral antibiotics <= 2 weeks prior
to registration).

- Pregnant or breast-feeding women.

- Curable with any other therapeutic interventions.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of Participants With Successful Engraftment

Outcome Time Frame:

Assessed daily during inpatient stay

Safety Issue:

No

Principal Investigator

Francine M. Foss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

CDR0000285659

NCT ID:

NCT00057954

Start Date:

June 2005

Completion Date:

May 2011

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent adult T-cell leukemia/lymphoma
  • anaplastic large cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
St. Mary - Corwin Regional Medical CenterPueblo, Colorado  81004
North Suburban Medical CenterThornton, Colorado  80229
Tufts-NEMC Cancer CenterBoston, Massachusetts  02111
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903