Hodgkin's DiseasePhase 2NCT00385788
Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
A Phase 2 study testing Gemcitabine, Fludarabine and Melphalan in people with Hodgkin's Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. 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?
- Gemcitabine, Fludarabine and Melphalan
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2016
- 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 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 refractory or relapsed Hodgkin's disease (including patients who fail or relapse after autologous SCT). This upper age limit will apply to transplants from both matched related and unrelated donors.
- Patients should have any of the following disease status: a. responsive or stable disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e. not rapidly progressive) relapses.
- Patients must have a serum bilirubin equal to or </=2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT) equal to or </= 3 times the upper limit of the normal range, serum creatinine <2.0 mg/dl (provided they also have a glomerular filtration rate of at least 55 ml/min), no symptomatic cardiac or pulmonary disease and a performance status equal to or </=2. Left ventricular ejection fraction >/= 40%, forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% predicted.
- Patients must have an HLA-compatible related or unrelated 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 matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8 of 8 match") is required.
- Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant. Men should be advised to not father a child while on treatment. Both women of childbearing potential and men must agree to practice effective methods of contraception.
- Patients must be capable and willing to sign informed consent.
Who cannot join
- Patients with documented disease progression on salvage chemotherapy.
- Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
- Severe concomitant medical or psychiatric illness.
- Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
- Chronic active hepatitis or cirrhosis.
- Active or uncontrolled infection.
- Radiation therapy involving chest (axilla excluded), mediastinum, or abdomen (i.e., small or large bowel) completed within 10 weeks of transplant admission. Radiation therapy shortly before the start of the preparative regimen is allowed.
- Prior or concurrent malignancies (including myelodysplasia) except resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Chair. Cancer treated with curative intent > 5 years previously will be allowed.
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: Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Read the detailed description
Central Venous Catheter:
If you choose to take part in this study, the chemotherapy, some of the other drugs in this study, and the stem cell transplant and immune cells will be given by vein through your central venous catheter (CVC). A CVC is a sterile flexible tube and needle that will be placed into a large vein while you are under local anesthesia. Blood samples will also be drawn through your CVC. The CVC will remain in your body during treatment. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
Study Drug Administration:
The days before you receive your stem cells are called minus days, such as Day -2, Day -1. The day you receive the stem cells is called Day 0. The days after you receive the stem cells are called plus days, such as Day +1, Day +2.
On Day -7, you will receive gemcitabine by vein over about 40-180 minutes.
On Day -6, you will be admitted to the hospital and given fluids by vein to hydrate you.
On Days -5 and -4, you will receive fludarabine by vein over about 30 minutes.
On Days -4 and -3, you will receive thymoglobulin, if you are receiving a transplant from a matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), you will also receive antithymocyte globulin (ATG)
On Days -3 and -2, you will receive fludarabine by vein over about 30 minutes and melphalan over about 30 minutes.
On Day -1, you will "rest" (not receive chemotherapy).
On Day 0, you will receive the donor's stem cells and immune cells by vein. The infusion will last anywhere from about 30 minutes to several hours. You may be given other standard drugs to help lower the risk of side effects. You may ask the study staff for more information about how the drugs are given and their risks. All participants are expected to need blood transfusions as part of this treatment.
Beginning on Day -2, tacrolimus will be given by vein over 24 hours to help lower the risk of graft-versus-host disease (GVHD). This will be changed to pills once you can tolerate swallowing pills. If no active cancer is detected and there is no GVHD, you will then swallow 1 or more tacrolimus pills a day for only about 3-4 months, instead of the usual period of 6 months. This is done to boost the donor immune system against the cancer.
Starting 1 week after the transplant (Day +7), you will receive filgrastim (G-CSF) as an injection under the skin 1 time each day until your blood cell levels return to normal. Filgrastim is designed to make white blood cells grow, which may help to fight infections.
On Days +1, +3, +6, and +11, you will receive methotrexate by vein to decrease the risk of GVHD.
If you have persistent but stable (not "growing") disease after transplant, you will have your immunosuppressive medications (tacrolimus, corticosteroids) stopped even before 4 months. If there is no response, you will receive an infusion of additional cells from your donor.
Study Visits:
About 30 days before receiving the stem cells, you will have computed tomography (CT) and/or positron emission tomography (PET) scans to check the status of the disease.
About every day until discharge, and then at least weekly:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests.
Follow-Up Visits:
About 100 days after the transplant:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests. Part of the blood sample may be used for chimerism analysis (determination of donor or recipient cells), if needed.
- At any point that your doctor thinks they are needed, you will have a bone marrow aspiration, chest x-rays, and CT and/or PET scans to check the status of the disease. To collect a bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
About 6 months, 1 year, then annually after the transplant:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests. Part of the blood sample may be used for chimerism analysis (determination of donor or recipient cells), if needed. Part of the blood will be used to check your thyroid function once a year.
- At any point that your doctor thinks they are needed, you will have a bone marrow aspiration, chest x-rays, and CT and/or PET scans to check the status of the disease.
- You may have lung function tests, if your doctor thinks it is needed.
- About 6 months after the transplant, you may have a biopsy, if your doctor thinks it is needed.
- About once a year, you will have an eye exam.
The above tests/procedures may be repeated more often, if you doctor thinks it is needed.
The study staff will also stay in contact with your local doctor to find out if the disease comes back and to check how you are doing.
Length of Treatment:
You will be on study for about 3 years. After 1 year, there is no study specific testing you will be required to complete. Your transplant doctor will perform routine standard of care follow-up that all patients receiving allogeneic stem cell transplantation receive.
You may be removed from the study early if the doctor thinks it is in your best interest, if the disease gets worse or comes back, if intolerable side effects occur, if you have graft failure (the transplanted cells do not grow), or if you are unable to follow study directions.
If for any reason you want to leave the study early, you must talk to the study doctor. It may be life-threatening to leave the study after you have started to receive the study drugs but before you receive the stem cell transplant because your blood cell counts will be dangerously low.
This is an investigational study. All of the drugs used in this study are FDA-approved and commercially available. Up to 70 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Hodgkin's Disease
- Being tested
- Gemcitabine, Fludarabine, Melphalan, Antithymocyte Globulin, Allogeneic Stem Cell Infusion
- Keywords
- Hodgkin's Disease, Stem Cell Transplantation, Antithymocyte Globulin, Gemcitabine, Gemzar, Fludarabine, Fludarabine Phosphate, Melphalan, Allogeneic stem cell transplantation, AST, SCT, ATG, Thymoglobulin
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar, Gemcitabine hydrochloride
800 mg/m^2 IV over 30 minutes on Day -7 (1 day)
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
33 mg/m^2 IV over 30 minutes Day -5 to Day -2 (4 days)
MelphalanDrug
70 mg/m^2 IV over 30 minutes on Day -3 to Day -2 (2 days)
Antithymocyte GlobulinDrug
Also called ATG, Thymoglobulin
2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation.
If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant.
Allogeneic Stem Cell InfusionProcedure or surgery
Also called AST, Stem Cell Transplantation, SCT
Infusion of stem cells on Day 0.
TacrolimusDrug
Also called Prograf
0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.
Filgrastim (G-CSF)Drug
Also called Granul
Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.
MethotrexateDrug
Also called MTX
5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Fludarabine + Melphalan | Experimental | Gemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes for one day; Fludarabine 33 mg/m^2 IV for 4 days; Melphalan 70 mg/m^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11. Receives: Drug: Gemcitabine; Drug: Fludarabine; Drug: Melphalan; Drug: Antithymocyte Globulin; Procedure: Allogeneic Stem Cell Infusion; Drug: Tacrolimus; Drug: Filgrastim (G-CSF); Drug: Methotrexate |
| Fludarabine + Melphalan | Experimental | Fludarabine 33 mg/m^2 IV for 4 days; Melphalan 70 mg/m^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11. Receives: Drug: Fludarabine; Drug: Melphalan; Drug: Antithymocyte Globulin; Procedure: Allogeneic Stem Cell Infusion; Drug: Tacrolimus; Drug: Filgrastim (G-CSF); Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant Related Mortality Rate
Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.
Measured: Transplant to 100 days 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 Oct 2006 (estimated)
- Study startJul 2005
- Primary completionAug 2016
- Study completionAug 2016
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 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT00385788
- Sponsor's protocol ID
- 2005-0015
- Other IDs
- NCI-2012-01376
- Status last verified
- Apr 2018
- First submitted
- 9 Oct 2006
- Last updated
- 9 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00385788
- Acronym / sponsor ID
- 2005-0015
- Conditions
- Hodgkin's Disease
- Keywords
- Hodgkin's Disease, Stem Cell Transplantation, Antithymocyte Globulin, Gemcitabine, Gemzar, Fludarabine, Fludarabine Phosphate, Melphalan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Posted 9 May 2018
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 learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Detailed description
Central Venous Catheter:
If you choose to take part in this study, the chemotherapy, some of the other drugs in this study, and the stem cell transplant and immune cells will be given by vein through your central venous catheter (CVC). A CVC is a sterile flexible tube and needle that will be placed into a large vein while you are under local anesthesia. Blood samples will also be drawn through your CVC. The CVC will remain in your body during treatment. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
Study Drug Administration:
The days before you receive your stem cells are called minus days, such as Day -2, Day -1. The day you receive the stem cells is called Day 0. The days after you receive the stem cells are called plus days, such as Day +1, Day +2.
On Day -7, you will receive gemcitabine by vein over about 40-180 minutes.
On Day -6, you will be admitted to the hospital and given fluids by vein to hydrate you.
On Days -5 and -4, you will receive fludarabine by vein over about 30 minutes.
On Days -4 and -3, you will receive thymoglobulin, if you are receiving a transplant from a matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), you will also receive antithymocyte globulin (ATG)
On Days -3 and -2, you will receive fludarabine by vein over about 30 minutes and melphalan over about 30 minutes.
On Day -1, you will "rest" (not receive chemotherapy).
On Day 0, you will receive the donor's stem cells and immune cells by vein. The infusion will last anywhere from about 30 minutes to several hours. You may be given other standard drugs to help lower the risk of side effects. You may ask the study staff for more information about how the drugs are given and their risks. All participants are expected to need blood transfusions as part of this treatment.
Beginning on Day -2, tacrolimus will be given by vein over 24 hours to help lower the risk of graft-versus-host disease (GVHD). This will be changed to pills once you can tolerate swallowing pills. If no active cancer is detected and there is no GVHD, you will then swallow 1 or more tacrolimus pills a day for only about 3-4 months, instead of the usual period of 6 months. This is done to boost the donor immune system against the cancer.
Starting 1 week after the transplant (Day +7), you will receive filgrastim (G-CSF) as an injection under the skin 1 time each day until your blood cell levels return to normal. Filgrastim is designed to make white blood cells grow, which may help to fight infections.
On Days +1, +3, +6, and +11, you will receive methotrexate by vein to decrease the risk of GVHD.
If you have persistent but stable (not "growing") disease after transplant, you will have your immunosuppressive medications (tacrolimus, corticosteroids) stopped even before 4 months. If there is no response, you will receive an infusion of additional cells from your donor.
Study Visits:
About 30 days before receiving the stem cells, you will have computed tomography (CT) and/or positron emission tomography (PET) scans to check the status of the disease.
About every day until discharge, and then at least weekly:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests.
Follow-Up Visits:
About 100 days after the transplant:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests. Part of the blood sample may be used for chimerism analysis (determination of donor or recipient cells), if needed.
- At any point that your doctor thinks they are needed, you will have a bone marrow aspiration, chest x-rays, and CT and/or PET scans to check the status of the disease. To collect a bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
About 6 months, 1 year, then annually after the transplant:
- You will have a physical exam.
- Blood (about 4 tablespoons) will be drawn for routine tests. Part of the blood sample may be used for chimerism analysis (determination of donor or recipient cells), if needed. Part of the blood will be used to check your thyroid function once a year.
- At any point that your doctor thinks they are needed, you will have a bone marrow aspiration, chest x-rays, and CT and/or PET scans to check the status of the disease.
- You may have lung function tests, if your doctor thinks it is needed.
- About 6 months after the transplant, you may have a biopsy, if your doctor thinks it is needed.
- About once a year, you will have an eye exam.
The above tests/procedures may be repeated more often, if you doctor thinks it is needed.
The study staff will also stay in contact with your local doctor to find out if the disease comes back and to check how you are doing.
Length of Treatment:
You will be on study for about 3 years. After 1 year, there is no study specific testing you will be required to complete. Your transplant doctor will perform routine standard of care follow-up that all patients receiving allogeneic stem cell transplantation receive.
You may be removed from the study early if the doctor thinks it is in your best interest, if the disease gets worse or comes back, if intolerable side effects occur, if you have graft failure (the transplanted cells do not grow), or if you are unable to follow study directions.
If for any reason you want to leave the study early, you must talk to the study doctor. It may be life-threatening to leave the study after you have started to receive the study drugs but before you receive the stem cell transplant because your blood cell counts will be dangerously low.
This is an investigational study. All of the drugs used in this study are FDA-approved and commercially available. Up to 70 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Fludarabine + Melphalan | Experimental | Drug: Gemcitabine, Drug: Fludarabine, Drug: Melphalan, Drug: Antithymocyte Globulin, Procedure: Allogeneic Stem Cell Infusion, Drug: Tacrolimus, Drug: Filgrastim (G-CSF), Drug: MethotrexateGemcitabine 800 mg/m^2 intravenous (IV) over 30 minutes for one day; Fludarabine 33 mg/m^2 IV for 4 days; Melphalan 70 mg/m^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11. |
| Fludarabine + Melphalan | Experimental | Drug: Fludarabine, Drug: Melphalan, Drug: Antithymocyte Globulin, Procedure: Allogeneic Stem Cell Infusion, Drug: Tacrolimus, Drug: Filgrastim (G-CSF), Drug: MethotrexateFludarabine 33 mg/m^2 IV for 4 days; Melphalan 70 mg/m^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients < 65 years of age with histologically confirmed refractory or relapsed Hodgkin's disease (including patients who fail or relapse after autologous SCT). This upper age limit will apply to transplants from both matched related and unrelated donors.
- Patients should have any of the following disease status: a. responsive or stable disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e. not rapidly progressive) relapses.
- Patients must have a serum bilirubin equal to or </=2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT) equal to or </= 3 times the upper limit of the normal range, serum creatinine <2.0 mg/dl (provided they also have a glomerular filtration rate of at least 55 ml/min), no symptomatic cardiac or pulmonary disease and a performance status equal to or </=2. Left ventricular ejection fraction >/= 40%, forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% predicted.
- Patients must have an HLA-compatible related or unrelated 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 matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8 of 8 match") is required.
- Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant. Men should be advised to not father a child while on treatment. Both women of childbearing potential and men must agree to practice effective methods of contraception.
Key exclusion criteria (8 listed)
- Patients with documented disease progression on salvage chemotherapy.
- Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
- Severe concomitant medical or psychiatric illness.
- Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
- Chronic active hepatitis or cirrhosis.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar, Gemcitabine hydrochloride800 mg/m^2 IV over 30 minutes on Day -7 (1 day) | Drug | Gemcitabine + Fludarabine + Melphalan |
| FludarabineAlso: Fludarabine Phosphate, Fludara33 mg/m^2 IV over 30 minutes Day -5 to Day -2 (4 days) | Drug | Fludarabine + Melphalan, Gemcitabine + Fludarabine + Melphalan |
| Melphalan70 mg/m^2 IV over 30 minutes on Day -3 to Day -2 (2 days) | Drug | Fludarabine + Melphalan, Gemcitabine + Fludarabine + Melphalan |
| Antithymocyte GlobulinAlso: ATG, Thymoglobulin2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation. If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant. | Drug | Fludarabine + Melphalan, Gemcitabine + Fludarabine + Melphalan |
| Allogeneic Stem Cell InfusionAlso: AST, Stem Cell Transplantation, SCTInfusion of stem cells on Day 0. | Procedure or surgery | Fludarabine + Melphalan, Gemcitabine + Fludarabine + Melphalan |
| TacrolimusAlso: Prograf0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months. | Drug | Fludarabine + Melphalan, Gemcitabine + Fludarabine + Melphalan |
| Filgrastim (G-CSF)Also: GranulStarting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal. | Drug | Fludarabine + Melphalan, Gemcitabine + Fludarabine + Melphalan |
| MethotrexateAlso: MTX5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD. | Drug | Fludarabine + Melphalan, Gemcitabine + Fludarabine + Melphalan |
Primary outcome
Transplant Related Mortality Rate
Time frame: Transplant to 100 days post transplant
Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 Phase 2 study testing Gemcitabine, 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 6 inclusion and 8 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 9 May 2018. 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 9 May 2018). 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?
Transplant Related Mortality Rate (time frame: Transplant to 100 days post transplant). 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 9 May 2018.