LymphomaPhase 2NCT00506129
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
A Phase 2 study testing Fludarabine, Melphalan and Allogeneic Transplant in people with Lymphoma and Disorder Related to Bone Marrow Transplantation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Lymphoma, Disorder Related to Bone Marrow Transplantation
- What is being tested?
- Fludarabine, Melphalan and Allogeneic Transplant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jun 2015
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pathologically proven cutaneous T-cell lymphoma (CTCL), disease stage IIB to IVB, patients must be in at least a partial response-PR (skin and lymph nodes) after receiving other non-allogeneic transplant therapy, age </= 70 years, Zubrod performance status 0 or 1, left ventricular ejection fraction >/= 50% or approved for transplant by a cardiologist, DLCO >/= 50% predicted or approved for transplant by a pulmonologist, serum creatinine </= 1.5 mg/dL, serum bilirubin < 2mg/dL. SGPT < 3 x upper limit of normal, and no previous history of allogeneic transplantation.
- Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
Who cannot join
- 1) Patients cannot have active central nervous system (CNS) disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)
The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.
Read the detailed description
You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications.
The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions.
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given.
Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant.
You must stay in the Houston area for at least 100 days after the transplant. After 100 days, you must return to Houston every 3 months for 2 years for tests and checkups, then once a year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s), you will receive no further treatment.
This is an investigational study. The drugs used in this study are approved by the FDA and are commercially available. As many as 35 patients will take part in the study. All will be enrolled at MD Anderson.
- Being tested
- Fludarabine, Melphalan, Allogeneic Transplant, Thymoglobulin
- Keywords
- Cutaneous T-Cell Lymphoma, CTCL, Allogeneic Transplantation, Lymphoma, Allogeneic peripheral blood progenitor cell, PBPC, Bone Marrow transplantation, Stem Cell Transplant, SCT, Fludarabine, Fludarabine Phosphate, Fludara, Melphalan
- Medical subject headings
- Lymphoma, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.
MelphalanDrug
70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.
Allogeneic TransplantProcedure or surgery
Also called Allogeneic peripheral blood progenitor cell, PBPC, Bone Marrow transplantation, Stem Cell Transplant
Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.
ThymoglobulinDrug
Also called ATG, Antithymocyte Globulin
2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine + Melphalan with PBPC | Experimental | Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. Receives: Drug: Fludarabine; Drug: Melphalan; Procedure: Allogeneic Transplant; Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( > 90% to < 100%); only traces of disease remains; 2) Significant improvement ( > 75% to < 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( > 50% to < 75%); 4) Some improvement ( > 25% to < 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by > 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.
Measured: Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.
Secondary outcomes (1)
Average Overall Survival (OS) Length
OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days.
Measured: Baseline to disease progression, followed up to 5 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 posted25 Jul 2007 (estimated)
- Study startSep 2003
- Primary completionJun 2015
- Study completionJun 2015
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 LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chitra M. Hosing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506129
- Sponsor's protocol ID
- DM03-0279
- Other IDs
- NCI-2012-01547
- Status last verified
- Dec 2020
- First submitted
- 20 Jul 2007
- Last updated
- 29 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hosing C, Bassett R, Dabaja B, Talpur R, Alousi A, Ciurea S, Popat U, Qazilbash M, Shpall EJ, Oki Y, Nieto Y, Pinnix C, Fanale M, Maadani F, Donato M, Champlin R, Duvic M. Allogeneic stem-cell transplantation in patients with cutaneous lymphoma: updated results from a single institution. Ann Oncol. 2015 Dec;26(12):2490-5. doi: 10.1093/annonc/mdv473. Epub 2015 Sep 28.
PubMed 26416896
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)
- ClinicalTrials.gov ID
- NCT00506129
- Acronym / sponsor ID
- DM03-0279
- Keywords
- Cutaneous T-Cell Lymphoma, CTCL, Allogeneic Transplantation, Lymphoma, Allogeneic peripheral blood progenitor cell, PBPC, Bone Marrow transplantation, Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 29 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.
Detailed description
You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications.
The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions.
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given.
Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant.
You must stay in the Houston area for at least 100 days after the transplant. After 100 days, you must return to Houston every 3 months for 2 years for tests and checkups, then once a year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s), you will receive no further treatment.
This is an investigational study. The drugs used in this study are approved by the FDA and are commercially available. As many as 35 patients will take part in the study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludarabine + Melphalan with PBPC | Experimental | Drug: Fludarabine, Drug: Melphalan, Procedure: Allogeneic Transplant, Drug: ThymoglobulinFludarabine 25 mg/m^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with pathologically proven cutaneous T-cell lymphoma (CTCL), disease stage IIB to IVB, patients must be in at least a partial response-PR (skin and lymph nodes) after receiving other non-allogeneic transplant therapy, age </= 70 years, Zubrod performance status 0 or 1, left ventricular ejection fraction >/= 50% or approved for transplant by a cardiologist, DLCO >/= 50% predicted or approved for transplant by a pulmonologist, serum creatinine </= 1.5 mg/dL, serum bilirubin < 2mg/dL. SGPT < 3 x upper limit of normal, and no previous history of allogeneic transplantation.
- Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
Key exclusion criteria (1 listed)
- 1) Patients cannot have active central nervous system (CNS) disease.
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 |
|---|---|---|
| FludarabineAlso: Fludarabine Phosphate, Fludara25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant. | Drug | Fludarabine + Melphalan with PBPC |
| Melphalan70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant. | Drug | Fludarabine + Melphalan with PBPC |
| Allogeneic TransplantAlso: Allogeneic peripheral blood progenitor cell, PBPC, Bone Marrow transplantation, Stem Cell TransplantAllogeneic transplant given by vein after completion of Fludarabine and Melphalan. | Procedure or surgery | Fludarabine + Melphalan with PBPC |
| ThymoglobulinAlso: ATG, Antithymocyte Globulin2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. | Drug | Fludarabine + Melphalan with PBPC |
Primary outcome
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Time frame: Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.
Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( > 90% to < 100%); only traces of disease remains; 2) Significant improvement ( > 75% to < 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( > 50% to < 75%); 4) Some improvement ( > 25% to < 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by > 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.
1 secondary outcome
Average Overall Survival (OS) Length
Time frame: Baseline to disease progression, followed up to 5 years post transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26416896Hosing C, Bassett R, Dabaja B, Talpur R, Alousi A, Ciurea S, Popat U, Qazilbash M, Shpall EJ, Oki Y, Nieto Y, Pinnix C, Fanale M, Maadani F, Donato M, Champlin R, Duvic M. Allogeneic stem-cell transplantation in patients with cutaneous lymphoma: updated results from a single institution. Ann Oncol. 2015 Dec;26(12):2490-5. doi: 10.1093/annonc/mdv473. Epub 2015 Sep 28.
- University of Texas 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.
Chitra M. Hosing, 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 Phase 2 study testing Fludarabine, Melphalan and Allogeneic Transplant in people with Lymphoma and Disorder Related to Bone Marrow Transplantation, 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 2 inclusion and 1 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 29 Dec 2020. 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 29 Dec 2020). 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?
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) (time frame: Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.). 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 NCT00506129, 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 29 Dec 2020.