LymphomaEarly Phase 1NCT01022021
Peripheral Blood Stem Cell (PBSC) Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine
A Early Phase 1 study testing Rituximab and Bendamustine in people with Lymphoma, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Patients with certain types of cancer require treatment with very high doses of chemotherapy. A side effect of high chemotherapy doses is damage to the bone marrow where our blood and immune system cells are produced. Stem cells (or progenitor cells) are the source of all blood cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Rituximab and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 with relapsed or refractory C20+ non-Hodgkin's lymphoma (proven by biopsy, radiological findings or clinical exam) referred to BMT clinic of Kansas University Medical Center for consideration of autologous stem cell transplantation. No separate recruitment method or advertisement will be used to enroll patients.
- Age 18-70 years.
Who cannot join
- Pregnancy and nursing mother
- Karnofsky performance status less than 50%
- Life expectancy is severely limited by concomitant illness
- Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
- Symptomatic pulmonary disease precluding transplantation
- Serum creatinine greater than 1.8 mg/dL
Show all 10Show fewer
- Serum bilirubin greater than 2 times upper limit of normal, SGPT greater than 3 times upper limit of normal
- Evidence of chronic active hepatitis or cirrhosis
- Unable to sign informed consent
- Allergy to Rituximab
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66205
About this study
Official title: Adequacy of Peripheral Blood Stem Cell Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine: A Pilot Project and a Proof of Concept Study
Patients with certain types of cancer require treatment with very high doses of chemotherapy. A side effect of high chemotherapy doses is damage to the bone marrow where our blood and immune system cells are produced.
Stem cells (or progenitor cells) are the source of all blood cells. They are formed in the bone marrow (the spongy cavity in the center of large bones). The stem cells receive signals that direct them to become red cells, white cells or platelets. This happens before they are released into the blood stream. Stem cells circulating in the blood stream can be collected through a process called "apheresis" or "stem cell collection". The cells are then processed and frozen to preserve them. After chemotherapy has been given the stem cells are thawed and given back intravenously (IV: into the vein), like a blood transfusion. The stem cells in the collection will find their way back into the bone marrow space and, after a few days, will start to produce the blood and immune cells as they normally would. Having your own stem cells collected and returned to you later is called an "autologous transplant."
Read more
Non-Hodgkin's lymphoma is a disease in which malignant cancer cells form in the lymph system. Autologous stem cell transplantation is the standard of care for a chemo-sensitive relapse in patients with large cell lymphoma that has spread.
Bendamustine works by blocking the growth of cancer cells. It is used for the management of chronic lymphocytic leukemia and follicular lymphoma. Bendamustine in addition to rituximab (BR) is used in several trials in patients with lymphoma with encouraging results. Adequate peripheral blood stem cell (PBSC) collection is a pre-requisite for high dose therapy followed by cell transplantation in patients with relapsed lymphoma. Exposure to previous multiple chemotherapy and radiation treatment may lead to poor mobilization of PBSC. It is not known whether pre-treatment with bendamustine will adversely affect the process of PBSC mobilization and harvest. On the other hand, it is assumed that high dose alkylating agents like cyclophosphamide may actually help in breaking the bond between stem cells and the stromal cells in the marrow cavity and hence may lead to a better mobilization of PBSC.
- Conditions
- Lymphoma
- Being tested
- Rituximab, Bendamustine
- Keywords
- non-Hodgkin's lymphoma, autologous stem cell transplant
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
Day 1 - rituximab, 375 mg/M2 IV (drug dosage is based on body weight)
BendamustineDrug
Also called Treanda
Days 2 and 3 bendamustine, 90 mg/M2 IV over 30-60 minutes (drug dosage based on body weight)
| Study group | Role | What they receive |
|---|---|---|
| rituximab | Active comparator | Not described Receives: Drug: Rituximab |
| bendamustine | Active comparator | bendamustine, 90 mg/M2 Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of G-CSF induced PBSC mobilization after two cycles of rituximab and Bendamustine (BR) as salvage therapy in patients with relapsed non-Hodgkins lymphoma
Measured: Quarterly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Siddhartha Ganguly, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022021
- Sponsor's protocol ID
- 11908
- Status last verified
- Jan 2017
- First submitted
- 25 Nov 2009
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Peripheral Blood Stem Cell Mobilization in Patients With Relapsed Lymphoma Treated With Bendamustine: A Pilot Project and a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT01022021
- Acronym / sponsor ID
- 11908
- Conditions
- Lymphoma
- Keywords
- non-Hodgkin's lymphoma, autologous stem cell transplant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with certain types of cancer require treatment with very high doses of chemotherapy. A side effect of high chemotherapy doses is damage to the bone marrow where our blood and immune system cells are produced.
Stem cells (or progenitor cells) are the source of all blood cells. They are formed in the bone marrow (the spongy cavity in the center of large bones). The stem cells receive signals that direct them to become red cells, white cells or platelets. This happens before they are released into the blood stream. Stem cells circulating in the blood stream can be collected through a process called "apheresis" or "stem cell collection". The cells are then processed and frozen to preserve them. After chemotherapy has been given the stem cells are thawed and given back intravenously (IV: into the vein), like a blood transfusion. The stem cells in the collection will find their way back into the bone marrow space and, after a few days, will start to produce the blood and immune cells as they normally would. Having your own stem cells collected and returned to you later is called an "autologous transplant."
Non-Hodgkin's lymphoma is a disease in which malignant cancer cells form in the lymph system. Autologous stem cell transplantation is the standard of care for a chemo-sensitive relapse in patients with large cell lymphoma that has spread.
Bendamustine works by blocking the growth of cancer cells. It is used for the management of chronic lymphocytic leukemia and follicular lymphoma. Bendamustine in addition to rituximab (BR) is used in several trials in patients with lymphoma with encouraging results. Adequate peripheral blood stem cell (PBSC) collection is a pre-requisite for high dose therapy followed by cell transplantation in patients with relapsed lymphoma. Exposure to previous multiple chemotherapy and radiation treatment may lead to poor mobilization of PBSC. It is not known whether pre-treatment with bendamustine will adversely affect the process of PBSC mobilization and harvest. On the other hand, it is assumed that high dose alkylating agents like cyclophosphamide may actually help in breaking the bond between stem cells and the stromal cells in the marrow cavity and hence may lead to a better mobilization of PBSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rituximab | Active comparator | Drug: Rituximab |
| bendamustine | Active comparator | Drug: Bendamustinebendamustine, 90 mg/M2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with relapsed or refractory C20+ non-Hodgkin's lymphoma (proven by biopsy, radiological findings or clinical exam) referred to BMT clinic of Kansas University Medical Center for consideration of autologous stem cell transplantation. No separate recruitment method or advertisement will be used to enroll patients.
- Age 18-70 years.
Key exclusion criteria (10 listed)
- Pregnancy and nursing mother
- Karnofsky performance status less than 50%
- Life expectancy is severely limited by concomitant illness
- Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
- Symptomatic pulmonary disease precluding 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 |
|---|---|---|
| RituximabAlso: RituxanDay 1 - rituximab, 375 mg/M2 IV (drug dosage is based on body weight) | Drug | rituximab |
| BendamustineAlso: TreandaDays 2 and 3 bendamustine, 90 mg/M2 IV over 30-60 minutes (drug dosage based on body weight) | Drug | bendamustine |
Primary outcome
To assess the efficacy of G-CSF induced PBSC mobilization after two cycles of rituximab and Bendamustine (BR) as salvage therapy in patients with relapsed non-Hodgkins lymphoma
Time frame: Quarterly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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.
Siddhartha Ganguly, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rituximab and Bendamustine in people with Lymphoma, run by University of Kansas Medical Center 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 2 inclusion and 10 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 10 Jan 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the efficacy of G-CSF induced PBSC mobilization after two cycles of rituximab and Bendamustine (BR) as salvage therapy in patients with relapsed non-Hodgkins lymphoma (time frame: Quarterly). 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 10 Jan 2017.