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Completed

NCT Number: NCT01969435

Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma

Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative conditioning in lymphoma patients undergoing ASCT

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma.
  • Eligible for autologous stem cell transplantation.
  • 18 to 75 years of age at time of enrollment.
  • Adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral blood stem cell graft containing at least 2 x 10^6 CD34+ cells/kg based on patient body weight
  • ECOG performance status ≤ 2
  • Normal organ function as defined below:
  • Creatinine clearance > 40 ml/min
  • Total bilirubin ≤2.0 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • LVEF > 40% (by ECHO or MUGA)
  • FEV1 > 50% of predicted and DLCO > or = 50% of predicted
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion criteria

  • A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
  • Currently receiving any other experimental therapy or has received any other experimental therapy within the 4 weeks prior to enrollment.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan HCl for injection (propylene glycol-free), Captisol, or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and/or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
  • Known HIV-positivity. These patients are excluded because of the potential for pharmacokinetic interactions with the study regimen and their antiretroviral therapy and because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. .

Treatment and study plan

carmustine

Drug

Other names: BCNU, BiCNU®

Etoposide Phosphate

Drug

Other names: VP-16, Vepesid

Cytarabine

Drug

Other names: Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside, Ara-C

Melphalan HCl (propylene glycol-free)

Drug

Primary outcomes

  1. Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events

    Time frame: Day -7 through Day 30

    Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.

  2. Treatment-related Mortality (TRM)

    Time frame: 100 days

    TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant

Secondary outcomes

  1. Efficacy as Measured by Response Rates

    Time frame: Up to Day 100

    • The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion.
    • Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma
  2. Disease-free Survival

    Time frame: 1 year

    Percentage of patients who survive without any signs or symptoms of cancer at 1 year.

  3. Disease-free Survival

    Time frame: 2 years

    Percentage of patients who survive without any signs or symptoms of cancer at 2 years.

  4. Time to Engraftment (Neutrophil)

    Time frame: Assessed up to day 30

    Time from the date of the transplant to the date of neutrophil engraftment.

  5. Time to Engraftment (Platelet)

    Time frame: Assessed up to day 100

    Time from the date of transplant to the date of platelet engraftment.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

A Phase II Study of Melphalan HCl for Injection (Propylene Glycol-free), Combined With Carmustine, Etoposide, and Cytarabine (BEAM Regimen) for Myeloablative Conditioning in Lymphoma Patients Undergoing Autologous Stem Cell Transplantation

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Oct 25, 2013
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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