Hodgkin DiseasePhase 2NCT01969435
Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
A Phase 2 study testing Carmustine, Etoposide phosphate and Cytarabine in people with Hodgkin Disease and Lymphoma, Non-Hodgkin, run by Washington University School of Medicine at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin Disease, Lymphoma, Non-Hodgkin
- What is being tested?
- Carmustine, Etoposide phosphate and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2014to 31 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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. .
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
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
- Conditions
- Hodgkin Disease, Lymphoma, Non-Hodgkin
- Being tested
- Carmustine, Etoposide phosphate, Cytarabine, Melphalan HCl (propylene glycol-free)
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarmustineDrug
Also called BCNU, BiCNU®
Etoposide phosphateDrug
Also called VP-16, Vepesid
CytarabineDrug
Also called Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside
Melphalan HCl (propylene glycol-free)Drug
| Study group | Role | What they receive |
|---|---|---|
| Melphalan, carmustine, etoposide, cytarabine (BEAM) | Experimental | * Day -7, carmustine intravenous (IV) infusion
* Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day
* Day -2, melphalan HCl (propylene glycol-free)(IV) infusion
* Day 0, stem cell transplant. Receives: Drug: Carmustine; Drug: Etoposide phosphate; Drug: Cytarabine; Drug: Melphalan HCl (propylene glycol-free) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
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.
Measured: Day -7 through Day 30
Treatment-related Mortality (TRM)
TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant
Measured: 100 days
Secondary outcomes (5)
Efficacy as Measured by Response Rates
- 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
Measured: Up to Day 100
Disease-free Survival
Percentage of patients who survive without any signs or symptoms of cancer at 1 year.
Measured: 1 year
Disease-free Survival
Percentage of patients who survive without any signs or symptoms of cancer at 2 years.
Measured: 2 years
Time to Engraftment (Neutrophil)
Time from the date of the transplant to the date of neutrophil engraftment.
Measured: Assessed up to day 30
Time to Engraftment (Platelet)
Time from the date of transplant to the date of platelet engraftment.
Measured: Assessed up to day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study start19 Mar 2014
- Primary completion30 Sep 2015
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Cashen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969435
- Sponsor's protocol ID
- 201312115
- Status last verified
- Jan 2018
- First submitted
- 16 Oct 2013
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01969435
- Acronym / sponsor ID
- 201312115
- Conditions
- Hodgkin Disease, Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 19 Mar 2014 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Posted 11 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melphalan, carmustine, etoposide, cytarabine (BEAM) | Experimental | Drug: Carmustine, Drug: Etoposide phosphate, Drug: Cytarabine, Drug: Melphalan HCl (propylene glycol-free)* Day -7, carmustine intravenous (IV) infusion * Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day * Day -2, melphalan HCl (propylene glycol-free)(IV) infusion * Day 0, stem cell transplant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarmustineAlso: BCNU, BiCNU® | Drug | Melphalan, carmustine, etoposide, cytarabine (BEAM) |
| Etoposide phosphateAlso: VP-16, Vepesid | Drug | Melphalan, carmustine, etoposide, cytarabine (BEAM) |
| CytarabineAlso: Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside | Drug | Melphalan, carmustine, etoposide, cytarabine (BEAM) |
| Melphalan HCl (propylene glycol-free) | Drug | Melphalan, carmustine, etoposide, cytarabine (BEAM) |
Primary outcome
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.
Treatment-related Mortality (TRM)
Time frame: 100 days
TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant
5 secondary outcomes
Efficacy as Measured by Response Rates
Time frame: Up to Day 100
Disease-free Survival
Time frame: 1 year
Disease-free Survival
Time frame: 2 years
Time to Engraftment (Neutrophil)
Time frame: Assessed up to day 30
Time to Engraftment (Platelet)
Time frame: Assessed up to day 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Cashen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carmustine, Etoposide phosphate and Cytarabine in people with Hodgkin Disease and Lymphoma, Non-Hodgkin, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events (time frame: Day -7 through Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.