LeukemiaPhase 1NCT00410982
Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies
A Phase 1 study testing Busulfan, Gemcitabine and Melphalan in people with Leukemia and 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 find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- What is being tested?
- Busulfan, Gemcitabine and Melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - <70 years.
- Patients with lymphoid malignancies who do not qualify for treatment protocols of higher priority: 2.1) Primary refractory/recurrent Hodgkin's disease 2.2) Primary refractory/recurrent non-Hodgkin's lymphoma 2.3) Multiple myeloma beyond first remission or unresponsive to therapy, who do not qualify for higher priority melphalan-based protocols.
- Adequate renal function, as defined by estimated serum creatinine clearance >/= 50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- Adequate hepatic function, as defined by Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) </= 3 * upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 * upper limit of normal.
- Adequate pulmonary function with forced expiratory volume for 1 second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >/= 50% of expected corrected for hemoglobin or volume.
- Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
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- Zubrod performance status <2.
- Patient should be willing to participate in the study by providing written consent.
- 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 virus (HBV), 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.
- Human immunodeficiency virus (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.
About this study
Official title: Gemcitabine Combined With Busulfan and Melphalan, With Hematopoietic Cell Transplantation, for Patients With Poor-prognosis Advanced Lymphoid Malignancies
The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.
Read the detailed description
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 the tumor cells, by not allowing these cells to repair the DNA damage caused by busulfan or melphalan.
You will have apheresis done to collect some of your stem cells. Apheresis is the process of removing part of the blood (such as platelets or white blood cells) from the body in order to remove certain elements, such as stem cells. Then, the rest of the blood is returned back to your body. Your stem cells will be put back in your body after you finish receiving gemcitabine, busulfan, and melphalan. Apheresis will be done by a major vein through a central venous catheter (CVC), usually in the chest. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain these procedures to you in more detail, and you will be required to sign a separate consent form for each procedure.
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 2 participants to begin receiving the study drugs. The dose of the study drugs you receive will depend on when you enrolled in this study. If no intolerable side effects occur in your group, researchers will continue to enroll participants at the next highest dose level until the highest tolerable dose of the study drugs is found. The dose that you receive will remain the same throughout this study.
Before you start to receive chemotherapy at treatment doses, you will be given a very small test dose of busulfan. Blood (1 teaspoon) will be drawn to check the levels of the drug in your blood at ten different timepoints (5-6 tablespoons total). This will help the study staff calculate your treatment doses of this drug. If there is a schedule conflict and the laboratory is not available for this testing, this procedure will not be performed. In that case, you would receive an unchanging dose of busulfan during the treatment.
During Day 1 you will receive gemcitabine and busulfan by CVC.
On Days 2-4, you will receive busulfan.
On Day 5, you will not receive any study drugs.
On Day 6, you will receive gemcitabine followed by melphalan.
On Day 7, you will receive melphalan.
On Day 8, you will not receive any study drugs.
On Day 9, you will receive your autologous stem cells through a needle in your vein over about 30-60 minutes.
If you have a B-cell cancer, you will receive rituximab (a treatment used for certain lymphomas or chronic lymphocytic leukemia) as part of standard of care, 1 day after and again 8 days after the infusion of the autologous cells.
As part of standard care, you will receive G-CSF (filgrastim) as an injection just under your skin daily, starting 1 day after the transplant, until your blood cell levels return to normal.
As part of standard care, you will receive a total of 6 doses of palifermin by vein. Three (3) of the doses will be given before starting chemotherapy (with a 24-hour break between the last dose of palifermin and the first dose of chemotherapy), and 3 doses will be given after the last chemotherapy dose, starting on Day 0.
You will be taken off this study 100 days after the transplant. You may be taken off this study early if the disease gets worse or you experience any intolerable 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 will continue as an outpatient in the Houston area to be monitored for infections and transplant-related complications.
This is an investigational study. Busulfan, gemcitabine, and melphalan are all FDA approved and commercially available. The use of these study drugs together and the use of gemcitabine at these dose levels is investigational. Up to 143 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Busulfan, Gemcitabine, Melphalan, Hematopoietic Cell Transplantation, Rituximab for Patients with B-Cell Malignancies
- Keywords
- Lymphoid Malignancies, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Hematopoietic Cell Transplantation, Myeloma, Leukemia, Lymphoma, Busulfan, Busulfex, Myleran, Gemcitabine, Gemcitabine Hydrochloride, Gemzar, Melphalan, Alkeran
- Medical subject headings
- Leukemia, Lymphoma, Neoplasms, Plasma Cell, Hodgkin Disease, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Also called Busulfex, Myleran
Day -10 = 32 mg/m^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m^2 Intravenous
GemcitabineDrug
Also called Gemzar, Gemcitabine Hydrochloride
Day -8 = 75 mg/m^2 Intravenous bolus; Day -3 = 75 mg/m^2 Intravenous bolus.
MelphalanDrug
Also called Alkeran
Day -3 and Day -2 = 60 mg/m^2 Intravenous.
Hematopoietic Cell TransplantationOther
Also called Stem Cell Infusion, HCT
Infusion of stem cells on Day 0.
Rituximab for Patients with B-Cell MalignanciesDrug
Also called Rituxan
375 mg/m^2 Intravenous on Days 1 and 8.
PaliferminDrug
Also called Kepivance
60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Busulfan + Melphalan + HCT | Experimental | HCT = Hematopoietic Cell Transplantation Receives: Drug: Busulfan; Drug: Gemcitabine; Drug: Melphalan; Other: Hematopoietic Cell Transplantation; Drug: Rituximab for Patients with B-Cell Malignancies; Drug: Palifermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan
MTD defined as dose level where one of two participants enrolled at a given time have no dose limiting toxcities (DLT) at that dose level. Continual reassessment from baseline for DLT, monitored daily during hospitalization, weekly to Day 30 and monthly to Day 100. Dose level assessed with each 21-day dose escalation cycle, Gemcitabine delivered Day -8 to Day -5 of 21 day cycle.
Measured: Baseline to Day 100 post transplant, up to 115 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 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
- NCT00410982
- Sponsor's protocol ID
- 2006-0803
- Status last verified
- Sep 2012
- First submitted
- 11 Dec 2006
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- 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 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine Combined With Busulfan and Melphalan, With Hematopoietic Cell Transplantation, for Patients With Poor-prognosis Advanced Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00410982
- Acronym / sponsor ID
- 2006-0803
- Keywords
- Lymphoid Malignancies, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Hematopoietic Cell Transplantation, Myeloma, Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Dec 2006 (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.
The goal of this clinical research study is to find the highest tolerated dose of gemcitabine that can be given with busulfan and melphalan. The safety of this drug combination will also be studied.
Detailed description
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 the tumor cells, by not allowing these cells to repair the DNA damage caused by busulfan or melphalan.
You will have apheresis done to collect some of your stem cells. Apheresis is the process of removing part of the blood (such as platelets or white blood cells) from the body in order to remove certain elements, such as stem cells. Then, the rest of the blood is returned back to your body. Your stem cells will be put back in your body after you finish receiving gemcitabine, busulfan, and melphalan. Apheresis will be done by a major vein through a central venous catheter (CVC), usually in the chest. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain these procedures to you in more detail, and you will be required to sign a separate consent form for each procedure.
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 2 participants to begin receiving the study drugs. The dose of the study drugs you receive will depend on when you enrolled in this study. If no intolerable side effects occur in your group, researchers will continue to enroll participants at the next highest dose level until the highest tolerable dose of the study drugs is found. The dose that you receive will remain the same throughout this study.
Before you start to receive chemotherapy at treatment doses, you will be given a very small test dose of busulfan. Blood (1 teaspoon) will be drawn to check the levels of the drug in your blood at ten different timepoints (5-6 tablespoons total). This will help the study staff calculate your treatment doses of this drug. If there is a schedule conflict and the laboratory is not available for this testing, this procedure will not be performed. In that case, you would receive an unchanging dose of busulfan during the treatment.
During Day 1 you will receive gemcitabine and busulfan by CVC.
On Days 2-4, you will receive busulfan.
On Day 5, you will not receive any study drugs.
On Day 6, you will receive gemcitabine followed by melphalan.
On Day 7, you will receive melphalan.
On Day 8, you will not receive any study drugs.
On Day 9, you will receive your autologous stem cells through a needle in your vein over about 30-60 minutes.
If you have a B-cell cancer, you will receive rituximab (a treatment used for certain lymphomas or chronic lymphocytic leukemia) as part of standard of care, 1 day after and again 8 days after the infusion of the autologous cells.
As part of standard care, you will receive G-CSF (filgrastim) as an injection just under your skin daily, starting 1 day after the transplant, until your blood cell levels return to normal.
As part of standard care, you will receive a total of 6 doses of palifermin by vein. Three (3) of the doses will be given before starting chemotherapy (with a 24-hour break between the last dose of palifermin and the first dose of chemotherapy), and 3 doses will be given after the last chemotherapy dose, starting on Day 0.
You will be taken off this study 100 days after the transplant. You may be taken off this study early if the disease gets worse or you experience any intolerable 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 will continue as an outpatient in the Houston area to be monitored for infections and transplant-related complications.
This is an investigational study. Busulfan, gemcitabine, and melphalan are all FDA approved and commercially available. The use of these study drugs together and the use of gemcitabine at these dose levels is investigational. Up to 143 patients will take part in this study. All will be enrolled at M. D. Anderson.
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 + HCT | Experimental | Drug: Busulfan, Drug: Gemcitabine, Drug: Melphalan, Other: Hematopoietic Cell Transplantation, Drug: Rituximab for Patients with B-Cell Malignancies, Drug: PaliferminHCT = Hematopoietic Cell Transplantation |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 - <70 years.
- Patients with lymphoid malignancies who do not qualify for treatment protocols of higher priority: 2.1) Primary refractory/recurrent Hodgkin's disease 2.2) Primary refractory/recurrent non-Hodgkin's lymphoma 2.3) Multiple myeloma beyond first remission or unresponsive to therapy, who do not qualify for higher priority melphalan-based protocols.
- Adequate renal function, as defined by estimated serum creatinine clearance >/= 50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- Adequate hepatic function, as defined by Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (SGPT) </= 3 * upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 * upper limit of normal.
- Adequate pulmonary function with forced expiratory volume for 1 second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >/= 50% of expected corrected for hemoglobin 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 virus (HBV), 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 |
|---|---|---|
| BusulfanAlso: Busulfex, MyleranDay -10 = 32 mg/m^2 Intravenous Test Dose; Days -8 thru -5 = 105 mg/m^2 Intravenous | Drug | Gemcitabine + Busulfan + Melphalan + HCT |
| GemcitabineAlso: Gemzar, Gemcitabine HydrochlorideDay -8 = 75 mg/m^2 Intravenous bolus; Day -3 = 75 mg/m^2 Intravenous bolus. | Drug | Gemcitabine + Busulfan + Melphalan + HCT |
| MelphalanAlso: AlkeranDay -3 and Day -2 = 60 mg/m^2 Intravenous. | Drug | Gemcitabine + Busulfan + Melphalan + HCT |
| Hematopoietic Cell TransplantationAlso: Stem Cell Infusion, HCTInfusion of stem cells on Day 0. | Other | Gemcitabine + Busulfan + Melphalan + HCT |
| Rituximab for Patients with B-Cell MalignanciesAlso: Rituxan375 mg/m^2 Intravenous on Days 1 and 8. | Drug | Gemcitabine + Busulfan + Melphalan + HCT |
| PaliferminAlso: Kepivance60 microgram/kg by vein on Days -13 to -11 and Days 0, +1, +2 | Drug | Gemcitabine + Busulfan + Melphalan + HCT |
Primary outcome
Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan
Time frame: Baseline to Day 100 post transplant, up to 115 days
MTD defined as dose level where one of two participants enrolled at a given time have no dose limiting toxcities (DLT) at that dose level. Continual reassessment from baseline for DLT, monitored daily during hospitalization, weekly to Day 30 and monthly to Day 100. Dose level assessed with each 21-day dose escalation cycle, Gemcitabine delivered Day -8 to Day -5 of 21 day cycle.
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 3 Jun 2016.
- 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.
- The University of Texas MD Anderson Cancer Center official 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 1 study testing Busulfan, Gemcitabine and Melphalan in people with Leukemia and 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 9 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 3 Jun 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Gemcitabine with Busulfan + Melphalan (time frame: Baseline to Day 100 post transplant, up to 115 days). 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 NCT00410982, 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 3 Jun 2016.