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



Status:Completed
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:2/15/2018
Start Date:March 19, 2014
End Date:May 31, 2017

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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

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


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. .
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
from
Saint Louis, MO
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