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High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (BMT CTN 0803)

Phase 2
15 Years
Open (Enrolling)
Lymphoma, HIV

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Trial Information

High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (BMT CTN 0803)


Non-Hodgkin lymphoma (NHL) is an AIDS-defining diagnosis for patients infected with the
Human Immunodeficiency Virus (HIV). While the incidence of NHL has decreased amongst
HIV-infected patients since the advent of highly-active anti-retroviral therapy (HAART),
lymphoma remains a significant cause of death for this patient population. The prognosis for
patients with AIDS-related lymphoma is dramatically different in the era of HAART therapy.
In a comparison of treatment outcomes for patients treated before and after the advent of
HAART, there is a statistically significant improvement in the overall survival of patients
treated with HAART. Unfortunately, despite considerable advances in the treatment of
AIDS-related NHL, induction-failure and disease relapse remain key challenges. The
prognosis for patients with refractory and relapsed NHL is poor with overall survival rates
of less than 20 percent for patients treated with non-transplant salvage therapies. Based
upon a randomized trial and numerous phase II trials, high-dose therapy with autologous
hematopoietic cell transplantation (HCT) has been established as the standard of care for
patients with chemotherapy-sensitive relapsed non-Hodgkin lymphoma.


All patients must have chemosensitive disease as demonstrated by response to induction or
salvage chemotherapy. Patients must also have less than or equal to 10percent bone marrow
involvement after their most recent salvage therapy. Patients cannot have had prior
autologous or allogeneic HCT. Patients must initiate conditioning therapy within 3 months
of mobilization or bone marrow harvest.

Mobilization therapy may be employed per institutional guidelines. Patients must have an
adequate autograft to be eligible for the protocol. Patients may not have HIV refractory to
pharmacologic therapy. Patients must not have opportunistic infection that is not
responding to therapy. Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2
BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1
followed by autologous HCT.

Patients will be followed for 2 years post-transplant. Survival data, time to progression
data, progression-free survival data, time to progression after CR data, lymphoma
disease-free survival data, time to hematopoietic recovery data, hematologic function data,
toxicity data, incidence of infections, treatment-related mortality data, immunologic
reconstitution data, data assessing the impact of therapy on the HIV reservoir and microbial
gut translocation will be recorded and reported periodically to the BMT CTN Data and
Coordinating Center (DCC).

Inclusion Criteria:

- Diagnosis of persistent or recurrent WHO classification diffuse large B-cell
lymphoma, composite lymphoma with > 50% diffuse large B-cell lymphoma, mediastinal
B-cell lymphoma, immunoblastic, plasmablastic, Burkitt's or Burkitt-like or classical
Hodgkin's lymphoma. Patients transformed from follicular lymphoma are eligible for
the study, pending fulfillment of other criteria.

- 15 years old or older

- Three or fewer prior regimens of chemotherapy over the entire course of their disease
treatment (including one induction chemotherapy and no more than 2 salvage
chemotherapies). Monoclonal antibody therapy and involved field radiation therapy
will not be counted as prior therapies.

- All patients must have chemosensitive disease as demonstrated by at least a partial
response to induction or salvage therapy.

- Less than or equal to 10% bone marrow involvement.

- Patients with adequate organ function as measured by: a)Cardiac: American Heart
Association Class I: Patients with cardiac disease but without resulting limitation
of physical activity. Ordinary physical activity does not cause undue fatigue,
palpitation, dyspnea, or anginal pain. Additionally, all patients must have a left
ventricular ejection fraction at rest greater than or equal to 40% demonstrated by
MUGA or echocardiogram; b)Hepatic: (i) Bilirubin less than 2.0 mg/dL (except for
isolated hyperbilirubinemia attributed to Gilbert syndrome or antiretroviral therapy)
and ALT and AST greater than 3x the upper limit of normal; (ii) Concomitant
Hepatitis: Patients with chronic hepatitis B or C may be enrolled on the trial
providing the above criteria are met. In addition, no active viral replication -
undetectable (viral load less than 500 copies/ml) hepatitis B DNA level by PCR and no
clinical or pathologic evidence of irreversible chronic liver disease; c)Renal:
Creatinine clearance (calculated creatinine clearance is permitted) greater than 40
mL/min; d)Pulmonary: DLCO, FEV1, FVC greater than or equal to 45% of predicted
(corrected for hemoglobin).

- Autologous peripheral stem cell graft with a minimum of greater than or less than 1.5
x 10^6 CD 34+ cells/kg (target greater than or less than 2.0 x 10^6 CD 34+ cells/kg)
or if PBSC mobilization fails, cells can be obtained by bone marrow harvest per
institutional practices (in cases where bone marrow will be used for transplantation,
the required CD34+ dose does not apply and institutional requirements for total
nucleated cell dose should apply).

- Initiate conditioning therapy within 3 months of mobilization or bone marrow harvest.

- Signed informed consent.

- Patients on antiretroviral therapies (ARVs) can either have: a) Undetectable HIV
viral load (VL less than 50 copies); b) If VL detectable at less than 2000 copies/mL
must have review of previous antiretroviral regimens or previous genotypic or
phenotypic testing which indicate the ability to fully suppress virus by addition of
sensitive drugs. This review will be carried out by the ID specialist caring for the
patient; c)If VL detectable at greater than 2000 copies/mL, a current HIV genotype
and/or phenotype must be obtained. If a HAART regimen to which the patient's virus
is sensitive can be determined based on genotype and previous antiretroviral
experience, then the patient will be considered eligible in this regard. This review
will be carried out by the ID specialist caring for the patient.

Exclusion Criteria:

- Karnofsky performance score less than 70%.

- Uncontrolled bacterial, viral or fungal infection (currently taking medication and
with progression or no clinical improvement).

- Prior malignancy in the 5 years prior to enrollment except resected basal cell
carcinoma, treated cervical carcinoma in situ or Kaposi's sarcoma: a)Symptomatic
Kaposi's sarcoma currently requiring therapy is excluded (patients receiving topical
therapy for minimal disease are not included in this definition); b)Prior treatment
with topical agents, local radiation, or up to 6 cycles of cytotoxic chemotherapy at
least six months prior is permitted; c) Other cancers treated with curative intent
less than 5 years previously will not be allowed unless approved by the Medical
Monitor or Protocol Chair; d)Cancer treated with curative intent more than 5 years
previously will be allowed.

- Pregnant (positive β-HCG) or breastfeeding.

- Fertile men or women unwilling to use contraceptive techniques from the time of
initiation of mobilization until six-months post-transplant.

- Prior autologous or allogeneic HCT.

- Patients with evidence of MDS/AML or abnormal cytogenetic analysis indicative of MDS
on the pre-transplant bone marrow examination. Pathology report documentation need
not be submitted.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival

Outcome Description:

Assess the overall survival after autologous hematopoietic stem cell transplantation (HCT) for chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin's lymphoma in patients with HIV using BEAM for pre-transplant conditioning

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Joseph Alvarnas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

City of Hope National Medical Center


United States: Federal Government

Study ID:




Start Date:

February 2011

Completion Date:

June 2015

Related Keywords:

  • Lymphoma
  • HIV
  • HIV
  • B-cell Lymphoma
  • Burkitt's Lymphoma
  • Follicular Lymphoma
  • Hodgkin's Lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, B-Cell



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University Hospitals of Cleveland Cleveland, Ohio  44106
Rush University Medical Center Chicago, Illinois  60612-3824
City of Hope National Medical Center Los Angeles, California  91010
University of Rochester Rochester, New York  14642
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Emory University Atlanta, Georgia  30322
Ohio State University Medical Center Columbus, Ohio  43210
University of Texas, MD Anderson Cancer Center Houston, Texas  77030
Weill Cornell Medical College New York, New York  10021
BMT Program at Northside Hospital Atlanta, Georgia  30342
University of Florida College of Medicine Gainesville, Florida  32610
University of California San Diego Medical Center San Diego, California  92103-8409
Johns Hopkins Medical Institution Baltimore, Maryland  21205
UCLA, Center for Clinical AIDS Research and Education Los Angeles, California  90035
University of Maryland Medical Systems, Greenebaum Cancer Center Baltimore, Maryland  21201
University of Washington, Barnes Jewish Hospital St. Louis, Missouri  63110