Hodgkin's LymphomaPhase 1/2NCT02059239
Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma
A Phase 1/2 study testing Bendamustine, Carmustine and Etoposide in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- Bendamustine, Carmustine and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2014to 15 Jun 2020
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have histologically or cytologically confirmed relapsed or primary refractory lymphoma (including Hodgkin's Lymphoma) staged with Positron Emission Tomography (PET) scan to have
- Allogeneic arm:
- Progressive disease or
- No response to salvage therapy or
- Partial response to salvage therapy defined as > 50% reduction in bidirectional area of masses but standardized uptake value (SUV) remains ≥8 in at least some PET avid areas
- Prior autologous transplant
Show all 14Show fewer
- Autologous arm:
- Partial response of >50% reduction in bidirectional area of masses and SUV reduction to <8 in PET avid areas Subjects must have evaluable disease.
- Subjects must have received at least one induction therapy and one line of salvage therapy that each incorporate at least two drugs that are standard of care for lymphoma
- Age >18 years.
- Karnofsky Performance Score (KPS) ≥ 50%
- For autologous transplants: Subjects must have an adequate number of CD34+ stem cells collected to allow for transplantation. This number is defined as ≥ 2x106 CD34+ cells / kg body weight. If not previously collected and stored, the subject must be willing to undergo stem cell mobilization and collection as per standard practice. If sufficient cells cannot be collected, subjects will be offered the option to proceed with the allogeneic arm of the study.
- Male and female subjects must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Female subjects of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Known to be positive for HIV
- Subjects may not be receiving any other investigational agents (defined as non FDA-approved agents) at the time of initiating bendamustine regimen. However, the salvage therapy for lymphoma can be part of an ongoing clinical trial with an investigational agent.
- Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.
- The risks to an unborn fetus or potential risks in nursing infants are unknown.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any medications listed in the protocol.
- Subject with severely decreased Left Ventricular Ejection Fraction (LVEF) or severely impaired pulmonary function tests (PFT's)
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Pilot Study of a Sequential Regimen of Intensive Chemotherapy Followed by Autologous or Allogeneic Transplantation for Refractory Lymphoma (Non-Hodgkin's and Hodgkin's) and Phase 2 Expansion Cohort
This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant.
The purpose of this study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage (treatment used for relapsed disease) chemotherapy.
Read the detailed description
Subjects with Hodgkin's or Non-Hodgkin's lymphoma that did not respond to treatment or have disease that has returned after responding to previous treatment, and are in need of a stem cell transplant will be eligible for this pilot study. Thirty subjects will be enrolled, with 15 subjects assigned to the autologous transplant cohort (according to disease status and eligibility) and 15 subjects to the allogeneic transplant cohort (according to diseases status and eligibility).
Subjects will undergo the following a number of screening procedures to determine eligibility. All eligible subjects will receive bendamustine at a dose of 200 mg/ m2/ day for two days on Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Subjects will then receive the conditioning regimen, BEAM (carmustine, etoposide, cytarabine arabinoside, and Melphalan) and alemtuzumab for 6 days (Day -6 to Day -1) followed by an autologous or allogeneic transplant.
Subjects with pathological confirmed B-cell malignancies will also receive rituximab 375 mg/m2 on Days + 1 and +8 post-transplant. Subjects with T-cell lymphoma will be enrolled in the study but will not receive rituximab.
After the transplantation all subjects will receive medication to prevent graft vs host disease and supportive care to prevent infections. To speed up the recovery of stem cells, subjects will receive post-transplant filgrastim (G-CSF).
After discharge from the hospital, subjects will be seen regularly in the clinic for an exam and assessments. All these tests are considered standard of care.
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Being tested
- Bendamustine, Carmustine, Etoposide, Melphalan, Cytarabine
- Keywords
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Lymphoma, Transplant
- 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.
BendamustineDrug
Also called Treanda
Days - 24 and Day - 23 followed by a short break of 10 - 14 days.
CarmustineDrug
Also called Bicnu
300 mg/m2 on Day -6
EtoposideDrug
Also called Etopophos, Toposar
100 mg/m2 on days -5 to -2
MelphalanDrug
Also called Alkeran
140mg/m2 on Day -1
CytarabineDrug
Also called Ara-C
200 mg/m2 on days -5 to -2
AlemtuzumabDrug
Also called Campath
20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors
Autologous Stem Cell TransplantationBiological
Allogeneic Stem Cell TransplantationBiological
RituximabDrug
Also called Rituxan
Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
| Study group | Role | What they receive |
|---|---|---|
| Chemo plus Autologous Transplantation | Experimental | Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant Receives: Drug: Bendamustine; Drug: Carmustine; Drug: Etoposide; Drug: Melphalan; Drug: Cytarabine; Drug: Alemtuzumab; Biological: Autologous Stem Cell Transplantation; Drug: Rituximab |
| Chemo plus Allogeneic Transplantation | Experimental | Bendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant Receives: Drug: Bendamustine; Drug: Carmustine; Drug: Etoposide; Drug: Melphalan; Drug: Cytarabine; Drug: Alemtuzumab; Biological: Allogeneic Stem Cell Transplantation; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Able to Proceed to Transplant
Number of patients in each arm able to proceed to stem cell transplantation within 14 days of receiving bendamustine treatment
Measured: 14 days after bendamustine treatment
Number of Patients Achieving Neutrophil Engraftment
Proportion of patients who successfully achieve neutrophil engraftment after stem cell transplant, defined as an absolute neutrophil count of 500/mm3 or for three consecutive days.
Measured: 35 Days Post-Transplant
Number of Patients Achieving Platelet Engraftment
Proportion of patients who successfully achieve platelet engraftment after stem cell transplant, defined as a platelet count of >20k/microL for three consecutive days without transfusion support for seven consecutive days.
Measured: 74 Days Post-Transplant
Secondary outcomes (7)
Overall Survival at Day 100 Post-Transplant
The time from stem cell infusion (Day 0) to death from any cause.
Measured: From Day 0 until time of death, assessed up to 100 days post-transplant
Overall Survival at Day 365 Post-Transplant
The time from stem cell infusion (Day 0) to death from any cause.
Measured: From Day 0 until time of death, assessed up to 365 days post-transplant
Transplant-Related Mortality
Death due to any cause other than disease progression within first 100 days post-transplant.
Measured: From Day 0 until time of death, up to 100 days post-transplant.
Disease Response Following Salvage Chemotherapy
Proportion of patients achieving a complete remission (CR; disappearance of clinically overt disease with no FDG-avid lesions on PET scan), partial remission (PR; reduction in clinical disease buden and >50% bi-dimensional decrease in tumor size on imaging), stable disease (SD; failure to meet the criteria for CR, PR or PD with no new areas of disease involvement) or progressive disease (PD; the appearance of any new lesion >1.5cm in size or a greater than 50% increase in the diameter of a previously identified node of over 1cm in size), as per Cheson Criteria, following salvage chemotherapy with Bendamustine.
Measured: Within 14 days of salvage chemotherapy treatment
Disease Response 30 Days Post-Transplant
Proportion of patients achieving a complete remission (CR; disappearance of clinically overt disease with no FDG-avid lesions on PET scan), partial remission (PR; reduction in clinical disease buden and >50% bi-dimensional decrease in tumor size on imaging), stable disease (SD; failure to meet the criteria for CR, PR or PD with no new areas of disease involvement) or progressive disease (PD; the appearance of any new lesion >1.5cm in size or a greater than 50% increase in the diameter of a previously identified node of over 1cm in size), as per Cheson Criteria, 30 days following autologous or allogeneic stem cell transplant
Measured: 30 days after stem cell transplant
Disease Response at 1 Year Post-Transplant
Proportion of patients achieving a complete remission (CR; disappearance of clinically overt disease with no FDG-avid lesions on PET scan), partial remission (PR; reduction in clinical disease buden and >50% bi-dimensional decrease in tumor size on imaging), stable disease (SD; failure to meet the criteria for CR, PR or PD with no new areas of disease involvement) or progressive disease (PD; the appearance of any new lesion >1.5cm in size or a greater than 50% increase in the diameter of a previously identified node of over 1cm in size), as per Cheson Criteria, 1 year following autologous or allogeneic stem cell transplant
Measured: 1 year after stem cell transplant
Progression-Free Survival After Stem Cell Transplant
Time elapsed between stem cell transplant (Day 0) and disease progression, as defined by the Cheson Criteria (the appearance of any new lesion >1.5cm in size or a greater than 50% increase in the diameter of a previously identified node of over 1cm in size)
Measured: Stem cell transplant (Day 0) up to 2 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start4 Jun 2014
- Primary completion16 Dec 2019
- Study completion15 Jun 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsiporah Shore, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059239
- Sponsor's protocol ID
- 1208012875
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2014
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Orfali N, Jhanwar Y, Koo C, Pasciolla M, Baldo M, Cuvilly E, Furman R, Gergis U, Greenberg J, Guarneri D, Hsu JM, Leonard JP, Mark T, Mayer S, Maignan K, Martin P, Opong A, Pearse R, Phillips A, Rossi A, Ruan J, Rutherford SC, Ryan J, Suhu G, Van Besien K, Shore T. Sequential intensive chemotherapy followed by autologous or allogeneic transplantation for refractory lymphoma. Leuk Lymphoma. 2021 Jul;62(7):1629-1638. doi: 10.1080/10428194.2021.1881516. Epub 2021 Feb 13.
PubMed 33586581
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Sequential Regimen of Intensive Chemotherapy Followed by Autologous or Allogeneic Transplantation for Refractory Lymphoma (Non-Hodgkin's and Hodgkin's) and Phase 2 Expansion Cohort
- ClinicalTrials.gov ID
- NCT02059239
- Acronym / sponsor ID
- 1208012875
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Lymphoma, Transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is for men and women with whose lymphoma (non-Hodgkin or Hodgkin) did not respond to treatment or has returned after responding to previous therapy, and who are in need of a stem cell transplant.
The purpose of this study is to test the safety and effectiveness of giving the drug Bendamustine, followed by high dose chemotherapy, within two weeks prior to a stem cell transplant for lymphoma that has not achieved a complete response to salvage (treatment used for relapsed disease) chemotherapy.
Detailed description
Subjects with Hodgkin's or Non-Hodgkin's lymphoma that did not respond to treatment or have disease that has returned after responding to previous treatment, and are in need of a stem cell transplant will be eligible for this pilot study. Thirty subjects will be enrolled, with 15 subjects assigned to the autologous transplant cohort (according to disease status and eligibility) and 15 subjects to the allogeneic transplant cohort (according to diseases status and eligibility).
Subjects will undergo the following a number of screening procedures to determine eligibility. All eligible subjects will receive bendamustine at a dose of 200 mg/ m2/ day for two days on Days - 24 and Day - 23 followed by a short break of 10 - 14 days. Subjects will then receive the conditioning regimen, BEAM (carmustine, etoposide, cytarabine arabinoside, and Melphalan) and alemtuzumab for 6 days (Day -6 to Day -1) followed by an autologous or allogeneic transplant.
Subjects with pathological confirmed B-cell malignancies will also receive rituximab 375 mg/m2 on Days + 1 and +8 post-transplant. Subjects with T-cell lymphoma will be enrolled in the study but will not receive rituximab.
After the transplantation all subjects will receive medication to prevent graft vs host disease and supportive care to prevent infections. To speed up the recovery of stem cells, subjects will receive post-transplant filgrastim (G-CSF).
After discharge from the hospital, subjects will be seen regularly in the clinic for an exam and assessments. All these tests are considered standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemo plus Autologous Transplantation | Experimental | Drug: Bendamustine, Drug: Carmustine, Drug: Etoposide, Drug: Melphalan, Drug: Cytarabine, Drug: Alemtuzumab, Biological: Autologous Stem Cell Transplantation, Drug: RituximabBendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by autologous transplant |
| Chemo plus Allogeneic Transplantation | Experimental | Drug: Bendamustine, Drug: Carmustine, Drug: Etoposide, Drug: Melphalan, Drug: Cytarabine, Drug: Alemtuzumab, Biological: Allogeneic Stem Cell Transplantation, Drug: RituximabBendamustine 200 mg/ m2/ day on Days - 24 and Day - 23 followed by a short break of 10 - 14 days, followed by Melphalan, Carmustine, Etoposide, Cytarabine (BEAM) and alemtuzumab, plus rituximab for all b-cell malignancies, followed by allogeneic transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- must have histologically or cytologically confirmed relapsed or primary refractory lymphoma (including Hodgkin's Lymphoma) staged with Positron Emission Tomography (PET) scan to have
- Subjects must have received at least one induction therapy and one line of salvage therapy that each incorporate at least two drugs that are standard of care for lymphoma
- Age >18 years.
- Karnofsky Performance Score (KPS) ≥ 50%
- For autologous transplants: Subjects must have an adequate number of CD34+ stem cells collected to allow for transplantation. This number is defined as ≥ 2x106 CD34+ cells / kg body weight. If not previously collected and stored, the subject must be willing to undergo stem cell mobilization and collection as per standard practice. If sufficient cells cannot be collected, subjects will be offered the option to proceed with the allogeneic arm of the study.
Key exclusion criteria (7 listed)
- Known to be positive for HIV
- Subjects may not be receiving any other investigational agents (defined as non FDA-approved agents) at the time of initiating bendamustine regimen. However, the salvage therapy for lymphoma can be part of an ongoing clinical trial with an investigational agent.
- Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.
- The risks to an unborn fetus or potential risks in nursing infants are unknown.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to any medications listed in the protocol.
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 |
|---|---|---|
| BendamustineAlso: TreandaDays - 24 and Day - 23 followed by a short break of 10 - 14 days. | Drug | Chemo plus Allogeneic Transplantation, Chemo plus Autologous Transplantation |
| CarmustineAlso: Bicnu300 mg/m2 on Day -6 | Drug | Chemo plus Allogeneic Transplantation, Chemo plus Autologous Transplantation |
| EtoposideAlso: Etopophos, Toposar100 mg/m2 on days -5 to -2 | Drug | Chemo plus Allogeneic Transplantation, Chemo plus Autologous Transplantation |
| MelphalanAlso: Alkeran140mg/m2 on Day -1 | Drug | Chemo plus Allogeneic Transplantation, Chemo plus Autologous Transplantation |
| CytarabineAlso: Ara-C200 mg/m2 on days -5 to -2 | Drug | Chemo plus Allogeneic Transplantation, Chemo plus Autologous Transplantation |
| AlemtuzumabAlso: Campath20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors | Drug | Chemo plus Allogeneic Transplantation, Chemo plus Autologous Transplantation |
| Autologous Stem Cell Transplantation | Biological | Chemo plus Autologous Transplantation |
| Allogeneic Stem Cell Transplantation | Biological | Chemo plus Allogeneic Transplantation |
| RituximabAlso: RituxanOnly to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant | Drug | Chemo plus Allogeneic Transplantation, Chemo plus Autologous Transplantation |
Primary outcome
Number of Patients Able to Proceed to Transplant
Time frame: 14 days after bendamustine treatment
Number of patients in each arm able to proceed to stem cell transplantation within 14 days of receiving bendamustine treatment
Number of Patients Achieving Neutrophil Engraftment
Time frame: 35 Days Post-Transplant
Proportion of patients who successfully achieve neutrophil engraftment after stem cell transplant, defined as an absolute neutrophil count of 500/mm3 or for three consecutive days.
Number of Patients Achieving Platelet Engraftment
Time frame: 74 Days Post-Transplant
Proportion of patients who successfully achieve platelet engraftment after stem cell transplant, defined as a platelet count of >20k/microL for three consecutive days without transfusion support for seven consecutive days.
7 secondary outcomes
Overall Survival at Day 100 Post-Transplant
Time frame: From Day 0 until time of death, assessed up to 100 days post-transplant
Overall Survival at Day 365 Post-Transplant
Time frame: From Day 0 until time of death, assessed up to 365 days post-transplant
Transplant-Related Mortality
Time frame: From Day 0 until time of death, up to 100 days post-transplant.
Disease Response Following Salvage Chemotherapy
Time frame: Within 14 days of salvage chemotherapy treatment
Disease Response 30 Days Post-Transplant
Time frame: 30 days after stem cell transplant
Disease Response at 1 Year Post-Transplant
Time frame: 1 year after stem cell transplant
Progression-Free Survival After Stem Cell Transplant
Time frame: Stem cell transplant (Day 0) up to 2 years post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33586581Orfali N, Jhanwar Y, Koo C, Pasciolla M, Baldo M, Cuvilly E, Furman R, Gergis U, Greenberg J, Guarneri D, Hsu JM, Leonard JP, Mark T, Mayer S, Maignan K, Martin P, Opong A, Pearse R, Phillips A, Rossi A, Ruan J, Rutherford SC, Ryan J, Suhu G, Van Besien K, Shore T. Sequential intensive chemotherapy followed by autologous or allogeneic transplantation for refractory lymphoma. Leuk Lymphoma. 2021 Jul;62(7):1629-1638. doi: 10.1080/10428194.2021.1881516. Epub 2021 Feb 13.
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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.
Tsiporah Shore, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bendamustine, Carmustine and Etoposide in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell 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 14 inclusion and 7 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 21 Feb 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 21 Feb 2021). 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?
Number of Patients Able to Proceed to Transplant (time frame: 14 days after bendamustine treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059239, which also lists 1 linked publication.
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 21 Feb 2021.