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

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin Disease; Lymphoma, Non-Hodgkin

Intervention: Carmustine (Drug); Etoposide phosphate (Drug); Cytarabine (Drug); Melphalan HCl (propylene glycol-free) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Amanda Cashen, M.D., Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Amanda Cashen, M.D., Phone: 314-454-8304, Email: acashen@dom.wustl.edu

Summary

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

Clinical Details

Official 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety and Toxicity

Treatment-related mortality (TRM)

Secondary outcome:

Efficacy

1-year Disease-free survival

2-year Disease-free survival

Time to engraftment (neutrophil)

Time to engraftment (platelet)

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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. .

Locations and Contacts

Amanda Cashen, M.D., Phone: 314-454-8304, Email: acashen@dom.wustl.edu

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Amanda Cashen, M.D., Phone: 314-454-8304, Email: acashen@dom.wustl.edu
Camille Abboud, M.D., Sub-Investigator
John DiPersio, M.D., Ph.D., Sub-Investigator
Todd Fehniger, M.D., Ph.D., Sub-Investigator
Meagan Jacoby, M.D., Ph.D., Sub-Investigator
Iskra Pusic, M.D., Sub-Investigator
Rizwan Romee, M.D., Sub-Investigator
Mark Schroeder, M.D., Sub-Investigator
Keith Stockerl-Goldstein, M.D., Sub-Investigator
Michael Tomasson, M.D., Sub-Investigator
Geoffrey Uy, M.D., Sub-Investigator
Ravi Vij, M.D., Principal Investigator
Matthew Walter, M.D., Sub-Investigator
Lukas Wartman, M.D., Sub-Investigator
John Welch, M.D., Ph.D., Sub-Investigator
Peter Westervelt, M.D., Ph.D., Sub-Investigator
Tanya Wildes, M.D., Sub-Investigator
Additional Information

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Starting date: March 2014
Last updated: August 6, 2015

Page last updated: August 23, 2015

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