Hodgkin's LymphomaPhase 2NCT01203020
Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation
A Phase 2 study testing Busulfan and Fludarabine in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by West Virginia University at 1 site in United States.
Trial summary
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT) followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- Busulfan and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2010to 27 Sep 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years of age are eligible.
- Eligible histologies include:
- B-cell, T-cell or NK-cell NHL refractory to frontline or salvage therapy defined as failure to achieve complete or partial remission according to standard criteria.
- Diffuse large B-cell lymphoma relapsing within 12 months of finishing a rituximab containing first line chemotherapy regimen (regardless of response to salvage chemotherapy)or with evidence of c-myc. Primary refractory NHL (regardless of response to salvage chemotherapy).
- Hodgkin lymphoma which is chemorefractory after at least two prior therapies.
- Hodgkin and NHL in an untreated relapse.
Show all 15Show fewer
- Transformed NHL or chronic lymphocytic leukemia undergoing Richter's transformation (regardless of response to last chemotherapy). Patients with chemosensitive relapsed NHLs or Hodgkin lymphoma, but considered ineligible for curative therapy with autologous transplantation, because of (a) inability to collect stem cells, (b) prior autografting, (c) presence of myelodysplasia or (d) histology not considered curable with autografting in opinion of treating physician will be eligible.
- All patients must have at least one suitable HLA-matched sibling or volunteer unrelated donor available (according to institutional guidelines). HLA typing should be performed at least at serological level for HLA-A, -B, and -C and at allele level for HLA-DRB1. One antigen or allele level mismatch will be permitted between the donor and the recipient; however each donor/recipient pair must match at HLA-DRB1 at allele level.
- Patient must be able to provide informed consent.
- Left ventricular ejection fraction ≥ 40%. No uncontrolled arrhythmias or uncontrolled New York Heart Association class III-IV heart failure.
- Bilirubin, aspartate aminotransferase (AST), and Alanine transaminase (ALT) ≤ 3 x normal; and absence of hepatic cirrhosis.
- Adequate renal function as defined by a serum creatinine clearance of ≥ 40% of normal calculated by Cockcroft-Gault equation.
- DLCO (diffusion capacity; corrected for hemoglobin) or forced expiratory volume (FEV1) ≥ 50% of predicted.
- Karnofsky performance status ≥ 70.
- A negative pregnancy test will be required for all women of child bearing potential. Breast feeding is not permitted.
Who cannot join
- Patients eligible for potentially curative therapy with autologous transplantation.
- Patients with lymphoblastic lymphoma.
- Patients with positive human immunodeficiency virus (HIV) serology.
- Clinical evidence of uncontrolled bacterial, viral or fungal infection at the time of transplant conditioning.
- Prior allogeneic transplantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospitals Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
About this study
Official title: Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin's and Non-Hodgkin's Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation - A Multicenter Phase II Study
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT) followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.
Read the detailed description
This study hopes to learn if giving intravenous (IV) busulfan with fludarabine before (as a conditioning regimen) allogeneic hematopoietic progenitor cell transplantation (HPC) is safe and helps patients with Non-Hodgkin´s Lymphoma (NHL) and Hodgkin´s Lymphoma (HL). An HPC transplant takes cells from a donor´s bone marrow and, after chemotherapy treatment with a conditioning regimen, infuses the donor´s cells into the patient´s body. Busulfan is a strong drug that suppresses the immune system and fludarabine is a chemotherapy (cancer fighting) drug. These drugs can stop the growth of cancer cells by breaking the Deoxyribonucleic acid (DNA) or genetic material which is necessary for the growth of both healthy and cancer cells. The use of IV busulfan with fludarabine as a conditioning regimen prior to HPC transplant is investigational (not approved by the Food and Drug Administration [FDA]).
Busulfan is only given once daily by IV in this study, which is also not approved by the FDA. Patients in this study will go through standard procedures for their disease like medical history, physical exam, blood tests, Multi Gated Acquisition Scan (MUGA) scan or echocardiogram, bone marrow aspirate or biopsy, and lung functions test. Patients will be asked to donate additional blood and bone marrow for this study and for potential future research on their blood related to this study. Because of the normal procedures for HPC transplants patients in this study will be hospitalized for 4 to 6 weeks or longer and will make frequent trips to the clinic to visit the study doctor for supervision for at least one year. Each patient will also have to have a central venous catheter inserted into a large vein above the heart. This is used to give the drugs and to take blood samples.
Participation in this study will last about two years. The study expects to enroll 32 patients and will open to at least two collaborating institutions in the future. Upon initial Institutional Review Board (IRB) approval enrollment will only occur at West Virginia University (WVU). The IRB will be notified before enrollment occurs at other institutions.
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Being tested
- Busulfan, Fludarabine
- Keywords
- Hodgkin's, non-Hodgkin's, lymphomas, allogeneic hematopoietic progenitor cell transplant, HPCT, busulfex, fludarabine, reduced-toxicity conditioning, reduced-intensity conditioning
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Also called Busulfex
Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6
FludarabineDrug
Also called Fludarabine Monophosphate, Fludara
Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic hematopoietic progenitor cell transplant | Experimental | Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Receives: Drug: Busulfan; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of 1 Year Overall Survival (OS)
Percentage of participants--1 year overall survival (OS) following transplantation.
Measured: 1 year
Percentage of 2 Year Overall Survival (OS)
Percentage of participants-- 2 Year Overall Survival (OS) post transplant
Measured: At 2nd year
Percentage of 1-year Progression Free Survival (PFS)
Percentage of 1-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine.
Measured: At 1 year
Percentage of 2-year Progression Free Survival (PFS)
Percentage of 2-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine.
Measured: At 2 year
Secondary outcomes (5)
Relapse Rate (RR) Following Transplantation at 1-year.
Percentage of participants Relapse Rates (RR) following transplantation at 1-year.
Measured: At 1 year
Relapse Rate (RR) Following Transplantation at 2-year.
Percentage of participants Relapse Rates (RR) following transplantation at 2-year.
Measured: At 2 year
Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year.
Percentage of participants NRM following RTC transplantation at 1-year.
Measured: At 1 year
Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years.
Percentage of participants NRM following RTC transplantation at 2-year.
Measured: At 2 years
Rates of Acute and Chronic Graft Versus Host Disease (GVHD).
Count/Percentage rates of acute and chronic graft versus host disease (GVHD).
Measured: Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study start12 Oct 2010
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
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's LymphomaStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham Kanate, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203020
- Sponsor's protocol ID
- WVU 11310
- Status last verified
- Jun 2023
- First submitted
- 13 Sep 2010
- Last updated
- 13 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin's and Non-Hodgkin's Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation - A Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT01203020
- Acronym / sponsor ID
- WVU 11310
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Hodgkin's, non-Hodgkin's, lymphomas, allogeneic hematopoietic progenitor cell transplant, HPCT, busulfex, fludarabine, reduced-toxicity conditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 12 Oct 2010 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Posted 13 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT) followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.
Detailed description
This study hopes to learn if giving intravenous (IV) busulfan with fludarabine before (as a conditioning regimen) allogeneic hematopoietic progenitor cell transplantation (HPC) is safe and helps patients with Non-Hodgkin´s Lymphoma (NHL) and Hodgkin´s Lymphoma (HL). An HPC transplant takes cells from a donor´s bone marrow and, after chemotherapy treatment with a conditioning regimen, infuses the donor´s cells into the patient´s body. Busulfan is a strong drug that suppresses the immune system and fludarabine is a chemotherapy (cancer fighting) drug. These drugs can stop the growth of cancer cells by breaking the Deoxyribonucleic acid (DNA) or genetic material which is necessary for the growth of both healthy and cancer cells. The use of IV busulfan with fludarabine as a conditioning regimen prior to HPC transplant is investigational (not approved by the Food and Drug Administration [FDA]).
Busulfan is only given once daily by IV in this study, which is also not approved by the FDA. Patients in this study will go through standard procedures for their disease like medical history, physical exam, blood tests, Multi Gated Acquisition Scan (MUGA) scan or echocardiogram, bone marrow aspirate or biopsy, and lung functions test. Patients will be asked to donate additional blood and bone marrow for this study and for potential future research on their blood related to this study. Because of the normal procedures for HPC transplants patients in this study will be hospitalized for 4 to 6 weeks or longer and will make frequent trips to the clinic to visit the study doctor for supervision for at least one year. Each patient will also have to have a central venous catheter inserted into a large vein above the heart. This is used to give the drugs and to take blood samples.
Participation in this study will last about two years. The study expects to enroll 32 patients and will open to at least two collaborating institutions in the future. Upon initial Institutional Review Board (IRB) approval enrollment will only occur at West Virginia University (WVU). The IRB will be notified before enrollment occurs at other institutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic hematopoietic progenitor cell transplant | Experimental | Drug: Busulfan, Drug: FludarabineIntravenous busulfex 130mg/m2 on days -6 to -3 before transplant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients aged 18-70 years of age are eligible.
- Eligible histologies include:
- All patients must have at least one suitable HLA-matched sibling or volunteer unrelated donor available (according to institutional guidelines). HLA typing should be performed at least at serological level for HLA-A, -B, and -C and at allele level for HLA-DRB1. One antigen or allele level mismatch will be permitted between the donor and the recipient; however each donor/recipient pair must match at HLA-DRB1 at allele level.
- Patient must be able to provide informed consent.
- Left ventricular ejection fraction ≥ 40%. No uncontrolled arrhythmias or uncontrolled New York Heart Association class III-IV heart failure.
Key exclusion criteria (5 listed)
- Patients eligible for potentially curative therapy with autologous transplantation.
- Patients with lymphoblastic lymphoma.
- Patients with positive human immunodeficiency virus (HIV) serology.
- Clinical evidence of uncontrolled bacterial, viral or fungal infection at the time of transplant conditioning.
- Prior allogeneic transplantation.
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 |
|---|---|---|
| BusulfanAlso: BusulfexBusulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 | Drug | Allogeneic hematopoietic progenitor cell transplant |
| FludarabineAlso: Fludarabine Monophosphate, FludaraFludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3) | Drug | Allogeneic hematopoietic progenitor cell transplant |
Primary outcome
Percentage of 1 Year Overall Survival (OS)
Time frame: 1 year
Percentage of participants--1 year overall survival (OS) following transplantation.
Percentage of 2 Year Overall Survival (OS)
Time frame: At 2nd year
Percentage of participants-- 2 Year Overall Survival (OS) post transplant
Percentage of 1-year Progression Free Survival (PFS)
Time frame: At 1 year
Percentage of 1-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine.
Percentage of 2-year Progression Free Survival (PFS)
Time frame: At 2 year
Percentage of 2-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine.
5 secondary outcomes
Relapse Rate (RR) Following Transplantation at 1-year.
Time frame: At 1 year
Relapse Rate (RR) Following Transplantation at 2-year.
Time frame: At 2 year
Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year.
Time frame: At 1 year
Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years.
Time frame: At 2 years
Rates of Acute and Chronic Graft Versus Host Disease (GVHD).
Time frame: Day 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Abraham Kanate, MD principal investigator
West Virginia University
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 Busulfan and Fludarabine in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by West Virginia University 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 15 inclusion and 5 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 Jul 2023. 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 13 Jul 2023). 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?
Percentage of 1 Year Overall Survival (OS) (time frame: 1 year). The study lists 4 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 Jul 2023.