Blood and Marrow Transplant Clinical Trials Network (BMT CTN) High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (0803) - Catalog

Name

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

Accession Number

HLB01971919a

Acronym

BMT CTN-0803

Related studies

BSI Study IDs
Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

False

Specimen ID Type

Not Applicable (Data Only)

Study Website

https://bmtctn.net/bmt-ctn-studies

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Study type

Clinical Trial

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Procedure: Autologous transplant

Drug: BCNU

Drug: Etoposide

Drug: Cytarabine

Drug: Melphalan

Study Open Date (Data)

2019-01-15

Study Open Date (Specimens)

None

Date materials available

2019-01-14

Last updated

None

Study period

April 2010 – June 2016

Study Contacts
NHLBI Division

DBDR

Classification

---------

HIV study classification

HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

None

# of Returned Specimens

None

Conditions

HIV-1
Lymphoma

Objectives

To evaluate the effectiveness of autologous hematopoietic cell transplantation (AHCT) for HIV positive patients with chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin’s HIV-Related Lymphoma (HRL) who received carmustine, etoposide, cytarabine, and melphalan (BEAM) as the pre-transplant conditioning regimen.

Background

Patients with HIV have an increased risk for developing cancer, including Hodgkin and non-Hodgkin lymphoma. For most patients with chemotherapy-sensitive relapsed and persistent lymphoma, autologous hematopoietic cell transplantation (AHCT) has been the standard of care, but for many years, was contraindicated for HIV patients. This was due to the immunosuppressive qualities of the chemotherapeutic agents used in the pre-transplantation procedure. With the advent of combination anti-retroviral therapy (cART), HIV infected patients became less susceptible to opportunistic infections making them better candidates to receive AHCT. In the late 1990s, the use of AHCT was introduced for patients with high-risk, relapsed, and persistent HRL with favorable outcomes.

Participants

Forty-three participants were enrolled into the study. Participants were eligible if they were at least 15 years old, infected with HIV, and the HIV was responsive to pharmacological therapy. Participants were also required to have persistent or recurrent diffuse large B-cell, immunoblastic, plasmablastic, Burkitt or Burkitt-like non-Hodgkin lymphoma or classical Hodgkin lymphoma. Eligible participants also needed to have a Karnofsky performance status >70%, adequate organ function, and no prior history of autologous or allogeneic HCT.


Patients had to initiate their conditioning regimen within 3 months of mobilization or bone marrow harvest. Hematopoietic progenitor cell (HPC) mobilization was per institutional standards and patients were required to achieve adequate HPC mobilization (> 1.5 x 10^6 CD34+ cells/kg) to be eligible for the protocol.

Design

This was a prospective phase II multicenter trial where eligible participants received a modified BEAM treatment prior to the AHCT. The BEAM regimen consisted of carmustine 300 mg/m2 (day – 6), etoposide 100 mg/m2 twice daily (days −5 to −2), cytarabine 100 mg/m2 twice daily (days −5 to −2), and melphalan 140 mg/m2 (day −1). cART was held from the time of initiation of the BEAM regimen and resumed at least 7 days after completion of the preparative regimen or following recovery from transplant-related gastrointestinal toxicities.


Patients underwent AHCT on day 0 and received growth factor, transfusion, and antimicrobial supportive care per the respective institutional standard through the period of post-AHCT recovery.


The primary endpoint was 1-year overall survival after AHCT.

Conclusions

Participant outcomes in this study were compared with 151 matched Center for International Bone Marrow Transplant Research controls. Outcomes between HIV-infected patients and controls were not significantly different. Based on these results, HRL patients should be considered candidates for AHCT if they meet standard transplant criteria.


Alvarnas JC, Le Rademacher J, Wang Y, et al. Autologous hematopoietic cell transplantation for HIV-related lymphoma: results of the BMT CTN 0803/AMC 071 trial. Blood. 2016;128(8):1050-8.

Disease classification

Publications

Mat types

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

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  • Age
  • Sex
  • Race