Hodgkin's DiseaseNCT00423709
Allogeneic Blood Stem Cell Transplantation
A study testing Allogeneic Blood Stem Cell Transplantation, Fludarabine and Melphalan in people with Hodgkin's Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
1. To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's disease (HD). 2. To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Hodgkin's Disease
- What is being tested?
- Allogeneic Blood Stem Cell Transplantation, Fludarabine and Melphalan
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Aug 2007
- Phase
- Interventional
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients <65 years of age with histologically confirmed primary refractory or relapsed Hodgkin's disease. In the event of transplants from unrelated donors, the upper age limit will be 55 years.
- Patients who failed or relapsed after an autologous transplant are eligible.
- Patients should have responsive or stable disease on salvage chemotherapy. Patients with untreated, smoldering (i.e. not rapidly progressive) relapses are eligible. Patients who failed or relapsed after an autologous transplant are eligible.
- Patients must have a serum bilirubin <2.0 mg/dl, serum creatinine <2.0 mg/dl, no symptomatic cardiac or pulmonary disease and a PS<2. Life expectancy not severely limited by concomitant illness (>12 weeks). Left ventricular ejection fraction >50%.
- Patients must have an HLA-compatible donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells . In the event of transplants from unrelated donors, only fully serologically A-, B- and DR-matched donors (including donors having a single micromismatch by DR/DQ molecular typing) will be acceptable. HLA-compatible cord blood unit will also be acceptable for recipient with a body weight of 50 kg or less.
Who cannot join
- Patients with documented disease progression on salvage chemotherapy are not eligible.
- Uncontrolled arrhythmia or symptomatic cardiac disease. FEV1, FVC and DLCO less than 50% . Symptomatic pulmonary disease. Evidence of chronic active hepatitis or cirrhosis.
- Active or uncontrolled infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease
- To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's disease (HD).
- To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy.
- To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect.
Read the detailed description
All patients in this study must have a plastic tube (catheter) inserted into a vein under the collarbone. Drugs and stem cells will be given through this tube.
Fludarabine will be given through the catheter once a day for four days. Patients will also receive melphalan for two days through the catheter. Patients receiving a transplant from a matched unrelated donor (i.e. not a blood relative) or a mismatched related donor (i.e. a blood relative, but not a full match) will also receive antithymocyte globulin (ATG) once a day for three days. ATG can help preventing graft-versus-host disease. All patients are expected to need blood transfusions as part of this treatment.
Beginning two days before the transplant, tacrolimus will be given through the catheter. It will be given 24 hours a day until the patient can swallow. The patient will then swallow one or more tacrolimus pills a day for about 6 months.
On the transplant day ("day 0"), the stem cells or bone marrow obtained from the donor will be infused through the catheter ("transplant"). Drugs will be given to reduce the chance of allergic reactions. Starting on day 7 after the transplant, filgrastim will be given through a needle to increase the growth of white blood cells. Methotrexate will be given by IV on days 1,3,6, 11 after the transplant. The patient may require blood transfusions for the following 2-4 weeks and sometimes longer.
Patients with progressive ("growing") Hodgkin's disease after the transplant will initially be taken off their immunosuppressive medications (tacrolimus, corticosteroids). If there is no response to this maneuver, they will be considered for infusion of additional cells from their donors, with or without preceding chemotherapy Both these maneuvers may produce a response ("shrinkage") of the tumor. Patients with persistent but stable (not "growing") disease may also be treated in a similar fashion. Potential side effects of the infusion of additional cells include graft-versus-host disease and /or a generalized drop in the blood counts. Both of these conditions can be serious or life-threatening.
Blood, urine, bone marrow and x-ray examinations will be performed as necessary to monitor the results of bone marrow transplantation. Patients may require blood and platelet transfusions. Blood tests will be done daily while hospitalized and several times a week until the blood counts recover. Bone marrow aspiration and biopsies will be performed prior to the transplant, when the donated cells show signs of engraftment, and at other times during the next 1 to 3 years to evaluate the growth of the transplant marrow, to evaluate possible recurrence of malignancy and recovery of immunity.
This is an investigational study. Up to 50 patients will be treated on this study. If the initial results are discouraging, the study may be stopped after a minimum of four patients have been enrolled.
- Conditions
- Hodgkin's Disease
- Being tested
- Allogeneic Blood Stem Cell Transplantation, Fludarabine, Melphalan
- Keywords
- Hodgkin's Disease, Allogeneic Blood Stem Cell Transplantation, Bone Marrow Transplantation, Fludarabine, Melphalan
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Blood Stem Cell TransplantationProcedure or surgery
FludarabineDrug
MelphalanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startJan 1998
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Anderlini, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423709
- Sponsor's protocol ID
- DM97-259
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2007
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00423709
- Acronym / sponsor ID
- DM97-259
- Conditions
- Hodgkin's Disease
- Keywords
- Hodgkin's Disease, Allogeneic Blood Stem Cell Transplantation, Bone Marrow Transplantation, Fludarabine, Melphalan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 18 Jan 2007 (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.
- To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's disease (HD).
- To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy.
- To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect.
Detailed description
All patients in this study must have a plastic tube (catheter) inserted into a vein under the collarbone. Drugs and stem cells will be given through this tube.
Fludarabine will be given through the catheter once a day for four days. Patients will also receive melphalan for two days through the catheter. Patients receiving a transplant from a matched unrelated donor (i.e. not a blood relative) or a mismatched related donor (i.e. a blood relative, but not a full match) will also receive antithymocyte globulin (ATG) once a day for three days. ATG can help preventing graft-versus-host disease. All patients are expected to need blood transfusions as part of this treatment.
Beginning two days before the transplant, tacrolimus will be given through the catheter. It will be given 24 hours a day until the patient can swallow. The patient will then swallow one or more tacrolimus pills a day for about 6 months.
On the transplant day ("day 0"), the stem cells or bone marrow obtained from the donor will be infused through the catheter ("transplant"). Drugs will be given to reduce the chance of allergic reactions. Starting on day 7 after the transplant, filgrastim will be given through a needle to increase the growth of white blood cells. Methotrexate will be given by IV on days 1,3,6, 11 after the transplant. The patient may require blood transfusions for the following 2-4 weeks and sometimes longer.
Patients with progressive ("growing") Hodgkin's disease after the transplant will initially be taken off their immunosuppressive medications (tacrolimus, corticosteroids). If there is no response to this maneuver, they will be considered for infusion of additional cells from their donors, with or without preceding chemotherapy Both these maneuvers may produce a response ("shrinkage") of the tumor. Patients with persistent but stable (not "growing") disease may also be treated in a similar fashion. Potential side effects of the infusion of additional cells include graft-versus-host disease and /or a generalized drop in the blood counts. Both of these conditions can be serious or life-threatening.
Blood, urine, bone marrow and x-ray examinations will be performed as necessary to monitor the results of bone marrow transplantation. Patients may require blood and platelet transfusions. Blood tests will be done daily while hospitalized and several times a week until the blood counts recover. Bone marrow aspiration and biopsies will be performed prior to the transplant, when the donated cells show signs of engraftment, and at other times during the next 1 to 3 years to evaluate the growth of the transplant marrow, to evaluate possible recurrence of malignancy and recovery of immunity.
This is an investigational study. Up to 50 patients will be treated on this study. If the initial results are discouraging, the study may be stopped after a minimum of four patients have been enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients <65 years of age with histologically confirmed primary refractory or relapsed Hodgkin's disease. In the event of transplants from unrelated donors, the upper age limit will be 55 years.
- Patients who failed or relapsed after an autologous transplant are eligible.
- Patients should have responsive or stable disease on salvage chemotherapy. Patients with untreated, smoldering (i.e. not rapidly progressive) relapses are eligible. Patients who failed or relapsed after an autologous transplant are eligible.
- Patients must have a serum bilirubin <2.0 mg/dl, serum creatinine <2.0 mg/dl, no symptomatic cardiac or pulmonary disease and a PS<2. Life expectancy not severely limited by concomitant illness (>12 weeks). Left ventricular ejection fraction >50%.
- Patients must have an HLA-compatible donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells . In the event of transplants from unrelated donors, only fully serologically A-, B- and DR-matched donors (including donors having a single micromismatch by DR/DQ molecular typing) will be acceptable. HLA-compatible cord blood unit will also be acceptable for recipient with a body weight of 50 kg or less.
Key exclusion criteria (3 listed)
- Patients with documented disease progression on salvage chemotherapy are not eligible.
- Uncontrolled arrhythmia or symptomatic cardiac disease. FEV1, FVC and DLCO less than 50% . Symptomatic pulmonary disease. Evidence of chronic active hepatitis or cirrhosis.
- Active or uncontrolled infection.
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 |
|---|---|---|
| Allogeneic Blood Stem Cell Transplantation | Procedure or surgery | – |
| Fludarabine | Drug | – |
| Melphalan | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jan 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Paolo Anderlini, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic Blood Stem Cell Transplantation, Fludarabine and Melphalan in people with Hodgkin's Disease, run by M.D. Anderson Cancer 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 5 inclusion and 3 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 24 Jan 2012. 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.
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.
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 24 Jan 2012.