LymphomaPhase 2NCT01200329
High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease
A Phase 2 study testing Gemcitabine, Busulfan and Melphalan in people with Lymphoma, 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 the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Gemcitabine, Busulfan and Melphalan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 6 Dec 2018
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 to 70 years
- Patients with relapsed Hodgkin's disease and one or more of the following: 1) Less than complete response to first-line chemotherapy, 2) Relapse within 12 months of completion of first-line chemotherapy, 3) Relapse within a prior irradiation field, 4) Less than complete metabolic response to second-line chemotherapy, 5) Second relapse or beyond, 6) Extranodal disease at the time of relapse, 7) Presence of B symptoms at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease, 8) Bulky disease (defined as any lesion greater than 5 cm) at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease.
- Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min (using the Cockcroft-Gault formula: creatinine clearance = [(140-age)*kg/(72*serum creatinine)] * 0.85 if female) and/or serum creatinine </=1.8 mg/dL.
- Adequate hepatic function, as defined by SGOT and/or SGPT </=3 x upper limit of normal; serum bilirubin and alkaline phosphatase </=2 x upper limit of normal, unless due to disease involvement
- Adequate pulmonary function with FEV1, FVC and DLCO >/=50% of expected corrected for hemoglobin and/or volume.
- Adequate cardiac function with left ventricular ejection fraction >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Zubrod performance status <2.
- Negative Beta HCG text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
Who cannot join
- Patients with grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to </= grade 1.
- Patients with prior whole brain irradiation
- Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
- Patients having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment.
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: High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic Cell Support for Patients With Relapsed/Refractory Hodgkin's Disease
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.
Read the detailed description
Study Drugs:
Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. They are commonly used in stem cell transplantation.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan or melphalan.
Apheresis:
Your cells have previously been collected by a procedure called apheresis. Apheresis is the process of filtering part of the blood from the body in order to remove the stem cells. The rest of the blood is then returned back to your body. You signed a separate consent for this procedure.
Busulfan Test Dose:
You will receive a test dose of busulfan by vein over about 1 hour. This low-level test dose of busulfan is to check how the level of busulfan in your blood levels changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches your body size. You will most likely receive this as an outpatient during the week before you are admitted to the hospital. If it cannot be given as an outpatient, you will be admitted to the hospital on Day -11 (11 days before your stem cells are returned to your body) and the test dose will be given on Day -10.
About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing of busulfan. PK testing measures the amount of study drug in the body at different time points and will help the study doctor determine what your dose of busulfan should be on study. These blood samples will be drawn at various timepoints before you receive busulfan and over about the next 11 hours. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, you will receive the standard fixed dose of busulfan.
If you receive the busulfan test dose as an outpatient:
On Days -12 through Day -10, you will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
You will be admitted on Day -9 and will receive fluids by vein. You will begin to swish the liquids caphosol and glutamine in your mouth 4 times a day, for about 2 minutes each time. You will swish these liquids every day until you leave the hospital. These drugs are also used to help decrease the risk of side effects in the mouth and throat.
If you receive the busulfan test dose as an inpatient:
On Days -13 through Day -11, you will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
You will be admitted on Day -11 and will receive fluids by vein. You will begin to swish the liquids caphosol and glutamine in your mouth 4 times a day, for about 2 minutes each time. You will swish these liquids every day until you leave the hospital. These drugs are also used to help decrease the risk of side effects in the mouth and throat.
On Day -10 you will receive the Busulfan test dose by vein over 1 hour.
Study Drug Administration (for all patients):
On Days -9 through -2, you will receive dexamethasone by vein over about 15 minutes to help decrease the risk of the possible side effects of the study drugs.
On Days -8 through -5, you will receive busulfan by vein over about 3 hours each day.
On Days -8 and -3, you will receive gemcitabine by vein over about 4 hours on both days.
On Days -3 and -2, you will receive melphalan by vein over about 30 minutes on both days.
On Day -1, you will not receive any study drugs.
On Day 0, your stem cells will be returned to your body by vein over 30-60 minutes.
On Days 0 through 2, you will receive palifermin by vein over about 30 seconds each day.
Beginning on Day +5, you will receive filgrastim (a drug that helps with the growth of white blood cells) through a needle under your skin 1 time each day until your blood cell levels return to normal.
If your tumor cells are found to have the CD20 protein, you will receive rituximab by vein over 4-8 hours on Days 1 and 8, which is standard treatment for this type of tumor when combined with high-dose chemotherapy.
Study Tests:
While you are in the hospital, you will be checked for any side effects as part of your standard of care. Blood (about 2 teaspoons) will be drawn every day to check for side effects.
As part of standard care, you will remain in the hospital for about 3-4 weeks after transplantation. After you are released from the hospital, you must remain in the Houston area to be monitored for infections and other transplant side effects until about Day 30. During this time, you will return to the clinic 1 time each week and the following tests and procedures will be performed:
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Around Day 30, if your doctor thinks it is needed, you will have a positron-emission tomography/CT (PET/CT) and/or a CT scan of the chest, abdomen, and pelvis to check the status of the disease.
You will have a lung function test about 30-100 days after the transplant.
Length of Study:
You will be taken off study about 100 days after the transplant. You may be taken off study early if the disease gets worse or you experience any intolerable side effects.
You must talk to the study doctor if you want to leave the study early. It may be life-threatening to leave the study after you have begun to receive the study drugs but before you receive the stem cells.
End-of-Study Visit:
At Day 100, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If your doctor thinks it is needed, you will have a (PET/CT) and/or a CT scan of the chest, abdomen, and pelvis to check the status of the disease.
- If your doctor thinks it is needed, you will have a bone marrow biopsy to check the status of the disease.
This is an investigational study. Busulfan, gemcitabine, and melphalan are all FDA approved and commercially available for the treatment of lymphoma and several other tumors. The use of these study drugs together and the use of gemcitabine at the dose level used in this study is investigational.
- Conditions
- Lymphoma
- Being tested
- Gemcitabine, Busulfan, Melphalan, Stem Cell Transplantation, Palifermin
- Keywords
- Hodgkin's disease, Relapsed, Refractory, High-dose chemotherapy, Busulfan, Gemcitabine, Melphalan
- Medical subject headings
- Lymphoma, Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemcitabine Hydrochloride, Gemzar
2775 mg/m2 by vein over about 3 hours on days -8 and -3.
BusulfanDrug
Also called Busulfex, Myleran
32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient
AUC 4,000 by vein over about 3 hours on days -8 to -5.
MelphalanDrug
Also called Alkeran
60 mg/m2 by vein over about 30 minutes on days -3 and -2.
Stem Cell TransplantationProcedure or surgery
Also called SCT
Infusion of stem cells on Day 0.
PaliferminDrug
Also called Kepivance
60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Busulfan + Melphalan | Experimental | Gemcitabine 2775 mg/m2 by vein over about 3 hours on days -8 and -3. Busulfan 32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient. AUC 4,000 by vein over about 3 hours on days -8 to -5. Melphalan 60 mg/m2 by vein over about 30 minutes on days -3 and -2. Palifermin 60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2. Infusion of stem cells on Day 0. Receives: Drug: Gemcitabine; Drug: Busulfan; Drug: Melphalan; Procedure: Stem Cell Transplantation; Drug: Palifermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS) of Patients
The event-free survival (EFS) of patients with poor prognosis relapse or refractory Hodgkin's disease (HD) after high-dose chemotherapy (HDC) with Gemcitabine/Busulfan/Melphalan (GemBuMel). Event is defined as relapse, tumor progression or death.Progression free survival is the length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse. Toxicity is defined as the treatment related mortality (TRM) rate, which will be evaluated within 30 days post transplant, and this rate will be compared with the 5% maximum rate. For EFS analysis, patients who experience the tumor relapse, disease progression, or death will be considered to be an event.
Measured: Enrollment up to 2 years post transplant
Secondary outcomes (1)
Overall Survival (OS) of These Patients.
The overall survival is the length of time from the start of treatment (Auto SCT) for the cancer, that patients are diagnosed with are still alive until date of first documented progression or date of death from any cause. It is measured in months and assessed up to 84 months.
Measured: Beyond 100 days post transplant up to 84 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJun 2011
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yago Nieto, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200329
- Sponsor's protocol ID
- 2010-0142
- Other IDs
- NCI-2012-01885
- Status last verified
- Dec 2019
- First submitted
- 9 Sep 2010
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nieto Y, Gruschkus S, Valdez BC, Jones RB, Anderlini P, Hosing C, Popat U, Qazilbash M, Kebriaei P, Alousi A, Saini N, Srour S, Rezvani K, Ramdial J, Barnett M, Gulbis A, Shigle TL, Ahmed S, Iyer S, Lee H, Nair R, Parmar S, Steiner R, Dabaja B, Pinnix C, Gunther J, Cuglievan B, Mahadeo K, Khazal S, Chuang H, Champlin R, Shpall EJ, Andersson BS. Improved outcomes of high-risk relapsed Hodgkin lymphoma patients after high-dose chemotherapy: a 15-year analysis. Haematologica. 2022 Apr 1;107(4):899-908. doi: 10.3324/haematol.2021.278311.
PubMed 33951890
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic Cell Support for Patients With Relapsed/Refractory Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT01200329
- Acronym / sponsor ID
- 2010-0142
- Conditions
- Lymphoma
- Keywords
- Hodgkin's disease, Relapsed, Refractory, High-dose chemotherapy, Busulfan, Gemcitabine, Melphalan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 16 Dec 2019
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 the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory Hodgkin's disease. The safety of this study treatment will also be studied.
Detailed description
Study Drugs:
Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. They are commonly used in stem cell transplantation.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan or melphalan.
Apheresis:
Your cells have previously been collected by a procedure called apheresis. Apheresis is the process of filtering part of the blood from the body in order to remove the stem cells. The rest of the blood is then returned back to your body. You signed a separate consent for this procedure.
Busulfan Test Dose:
You will receive a test dose of busulfan by vein over about 1 hour. This low-level test dose of busulfan is to check how the level of busulfan in your blood levels changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches your body size. You will most likely receive this as an outpatient during the week before you are admitted to the hospital. If it cannot be given as an outpatient, you will be admitted to the hospital on Day -11 (11 days before your stem cells are returned to your body) and the test dose will be given on Day -10.
About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing of busulfan. PK testing measures the amount of study drug in the body at different time points and will help the study doctor determine what your dose of busulfan should be on study. These blood samples will be drawn at various timepoints before you receive busulfan and over about the next 11 hours. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, you will receive the standard fixed dose of busulfan.
If you receive the busulfan test dose as an outpatient:
On Days -12 through Day -10, you will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
You will be admitted on Day -9 and will receive fluids by vein. You will begin to swish the liquids caphosol and glutamine in your mouth 4 times a day, for about 2 minutes each time. You will swish these liquids every day until you leave the hospital. These drugs are also used to help decrease the risk of side effects in the mouth and throat.
If you receive the busulfan test dose as an inpatient:
On Days -13 through Day -11, you will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
You will be admitted on Day -11 and will receive fluids by vein. You will begin to swish the liquids caphosol and glutamine in your mouth 4 times a day, for about 2 minutes each time. You will swish these liquids every day until you leave the hospital. These drugs are also used to help decrease the risk of side effects in the mouth and throat.
On Day -10 you will receive the Busulfan test dose by vein over 1 hour.
Study Drug Administration (for all patients):
On Days -9 through -2, you will receive dexamethasone by vein over about 15 minutes to help decrease the risk of the possible side effects of the study drugs.
On Days -8 through -5, you will receive busulfan by vein over about 3 hours each day.
On Days -8 and -3, you will receive gemcitabine by vein over about 4 hours on both days.
On Days -3 and -2, you will receive melphalan by vein over about 30 minutes on both days.
On Day -1, you will not receive any study drugs.
On Day 0, your stem cells will be returned to your body by vein over 30-60 minutes.
On Days 0 through 2, you will receive palifermin by vein over about 30 seconds each day.
Beginning on Day +5, you will receive filgrastim (a drug that helps with the growth of white blood cells) through a needle under your skin 1 time each day until your blood cell levels return to normal.
If your tumor cells are found to have the CD20 protein, you will receive rituximab by vein over 4-8 hours on Days 1 and 8, which is standard treatment for this type of tumor when combined with high-dose chemotherapy.
Study Tests:
While you are in the hospital, you will be checked for any side effects as part of your standard of care. Blood (about 2 teaspoons) will be drawn every day to check for side effects.
As part of standard care, you will remain in the hospital for about 3-4 weeks after transplantation. After you are released from the hospital, you must remain in the Houston area to be monitored for infections and other transplant side effects until about Day 30. During this time, you will return to the clinic 1 time each week and the following tests and procedures will be performed:
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Around Day 30, if your doctor thinks it is needed, you will have a positron-emission tomography/CT (PET/CT) and/or a CT scan of the chest, abdomen, and pelvis to check the status of the disease.
You will have a lung function test about 30-100 days after the transplant.
Length of Study:
You will be taken off study about 100 days after the transplant. You may be taken off study early if the disease gets worse or you experience any intolerable side effects.
You must talk to the study doctor if you want to leave the study early. It may be life-threatening to leave the study after you have begun to receive the study drugs but before you receive the stem cells.
End-of-Study Visit:
At Day 100, the following tests and procedures will be performed:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If your doctor thinks it is needed, you will have a (PET/CT) and/or a CT scan of the chest, abdomen, and pelvis to check the status of the disease.
- If your doctor thinks it is needed, you will have a bone marrow biopsy to check the status of the disease.
This is an investigational study. Busulfan, gemcitabine, and melphalan are all FDA approved and commercially available for the treatment of lymphoma and several other tumors. The use of these study drugs together and the use of gemcitabine at the dose level used in this study is investigational.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Busulfan + Melphalan | Experimental | Drug: Gemcitabine, Drug: Busulfan, Drug: Melphalan, Procedure: Stem Cell Transplantation, Drug: PaliferminGemcitabine 2775 mg/m2 by vein over about 3 hours on days -8 and -3. Busulfan 32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient. AUC 4,000 by vein over about 3 hours on days -8 to -5. Melphalan 60 mg/m2 by vein over about 30 minutes on days -3 and -2. Palifermin 60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2. Infusion of stem cells on Day 0. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 12 to 70 years
- Patients with relapsed Hodgkin's disease and one or more of the following: 1) Less than complete response to first-line chemotherapy, 2) Relapse within 12 months of completion of first-line chemotherapy, 3) Relapse within a prior irradiation field, 4) Less than complete metabolic response to second-line chemotherapy, 5) Second relapse or beyond, 6) Extranodal disease at the time of relapse, 7) Presence of B symptoms at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease, 8) Bulky disease (defined as any lesion greater than 5 cm) at the time of persistent disease upon completion of first-line chemotherapy, or of relapse, progressive disease.
- Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min (using the Cockcroft-Gault formula: creatinine clearance = [(140-age)*kg/(72*serum creatinine)] * 0.85 if female) and/or serum creatinine </=1.8 mg/dL.
- Adequate hepatic function, as defined by SGOT and/or SGPT </=3 x upper limit of normal; serum bilirubin and alkaline phosphatase </=2 x upper limit of normal, unless due to disease involvement
- Adequate pulmonary function with FEV1, FVC and DLCO >/=50% of expected corrected for hemoglobin and/or volume.
Key exclusion criteria (7 listed)
- Patients with grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to </= grade 1.
- Patients with prior whole brain irradiation
- Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
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: Gemcitabine Hydrochloride, Gemzar2775 mg/m2 by vein over about 3 hours on days -8 and -3. | Drug | Gemcitabine + Busulfan + Melphalan |
| BusulfanAlso: Busulfex, Myleran32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient AUC 4,000 by vein over about 3 hours on days -8 to -5. | Drug | Gemcitabine + Busulfan + Melphalan |
| MelphalanAlso: Alkeran60 mg/m2 by vein over about 30 minutes on days -3 and -2. | Drug | Gemcitabine + Busulfan + Melphalan |
| Stem Cell TransplantationAlso: SCTInfusion of stem cells on Day 0. | Procedure or surgery | Gemcitabine + Busulfan + Melphalan |
| PaliferminAlso: Kepivance60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2. | Drug | Gemcitabine + Busulfan + Melphalan |
Primary outcome
Event-free Survival (EFS) of Patients
Time frame: Enrollment up to 2 years post transplant
The event-free survival (EFS) of patients with poor prognosis relapse or refractory Hodgkin's disease (HD) after high-dose chemotherapy (HDC) with Gemcitabine/Busulfan/Melphalan (GemBuMel). Event is defined as relapse, tumor progression or death.Progression free survival is the length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse. Toxicity is defined as the treatment related mortality (TRM) rate, which will be evaluated within 30 days post transplant, and this rate will be compared with the 5% maximum rate. For EFS analysis, patients who experience the tumor relapse, disease progression, or death will be considered to be an event.
1 secondary outcome
Overall Survival (OS) of These Patients.
Time frame: Beyond 100 days post transplant up to 84 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33951890Nieto Y, Gruschkus S, Valdez BC, Jones RB, Anderlini P, Hosing C, Popat U, Qazilbash M, Kebriaei P, Alousi A, Saini N, Srour S, Rezvani K, Ramdial J, Barnett M, Gulbis A, Shigle TL, Ahmed S, Iyer S, Lee H, Nair R, Parmar S, Steiner R, Dabaja B, Pinnix C, Gunther J, Cuglievan B, Mahadeo K, Khazal S, Chuang H, Champlin R, Shpall EJ, Andersson BS. Improved outcomes of high-risk relapsed Hodgkin lymphoma patients after high-dose chemotherapy: a 15-year analysis. Haematologica. 2022 Apr 1;107(4):899-908. doi: 10.3324/haematol.2021.278311.
- 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.
Yago Nieto, MD, PHD 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, Busulfan and Melphalan in people with Lymphoma, 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 8 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 16 Dec 2019. 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 16 Dec 2019). 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?
Event-free Survival (EFS) of Patients (time frame: Enrollment up to 2 years post transplant). 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 NCT01200329, 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 16 Dec 2019.