Chronic Lymphocytic LeukemiaPhase 2Flu-MelNCT00772811
Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma
A Phase 2 study testing Flu-Mel in people with Chronic Lymphocytic Leukemia and Lymphoma, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma
- What is being tested?
- Flu-Mel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2001to Dec 2010
- Phase
- Phase 2
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be 15 years of age or older and 65 years of age or younger
- Patients with CLL, lymphoma, or multiple myeloma will be included in this study
- No prior anti-cancer treatment should be done within 30 days.
- Informed consent should be given.
- Patients should have an HLA-identical or single HLA-locus mismatched donor.
- Karnofsky performance scale should be 50 or over (see Appendix I).
Who cannot join
- Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible.
- Patients with high serum creatinine level will be excluded.
- Patients should have uncontrolled infection.
- No major anticipated illness or organ failure incompatible with survival from stem cell transplant.
- Serum bilirubin less than or equal to 4.0 mg/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
Read the detailed description
Treatment plan
- Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2.
- Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
- Melphalan will be administered following the completion of Fludarabine infusion at day -2.
- In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4, -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po. Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2.
- Before the administration of melphalan, prehydration will be done intravenously with 0.9% NS 1L over 3 hours.
- 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered.
- Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days. Appropriate amount of KCl should be mixed.
- GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.
- Conditions
- Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma
- Being tested
- Flu-Mel
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu-MelDrug
Also called Fludara-Alkaran
- Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
- Melphalan will be administered following the completion of Fludarabine infusion at day -2.
| Study group | Role | What they receive |
|---|---|---|
| Flu-Mel | No intervention | Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2. Receives: Drug: Flu-Mel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)
-To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) following allogeneic nonmyeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen in patients with chronic lymphocytic leukemia (CLL), lymphoma, and multiple myeloma.
Measured: 9years
Secondary outcomes (1)
include tumor response, incidence of chronic GVHD, and immune reconstitution.
-The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution.
Measured: 9years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startJul 2001
- Primary completionSep 2010
- Study completionDec 2010
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 Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Je-Hwan Lee, Doctor, Principal investigator, COSAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772811
- Sponsor's protocol ID
- C-001
- Acronym
- Flu-Mel
- Status last verified
- Feb 2011
- First submitted
- 5 Oct 2008
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Lee KH. A Phase II Trial of Fludarabine/Melphalan 100 Conditioning Therapy Followed by Allogeneic Hematopoietic Cell Transplantation for Patients With Lymphoma. Clin Lymphoma Myeloma Leuk. 2015 Nov;15(11):655-63. doi: 10.1016/j.clml.2015.08.087. Epub 2015 Sep 3.
PubMed 26428486
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00772811
- Acronym / sponsor ID
- Flu-Mel / C-001
- Conditions
- Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Jul 2001
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Oct 2008 (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.
Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
Detailed description
Treatment plan
- Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2.
- Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
- Melphalan will be administered following the completion of Fludarabine infusion at day -2.
- In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4, -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po. Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2.
- Before the administration of melphalan, prehydration will be done intravenously with 0.9% NS 1L over 3 hours.
- 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered.
- Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days. Appropriate amount of KCl should be mixed.
- GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flu-Mel | No intervention | Drug: Flu-MelConditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 15 years of age or older and 65 years of age or younger
- Patients with CLL, lymphoma, or multiple myeloma will be included in this study
- No prior anti-cancer treatment should be done within 30 days.
- Informed consent should be given.
- Patients should have an HLA-identical or single HLA-locus mismatched donor.
Key exclusion criteria (5 listed)
- Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible.
- Patients with high serum creatinine level will be excluded.
- Patients should have uncontrolled infection.
- No major anticipated illness or organ failure incompatible with survival from stem cell transplant.
- Serum bilirubin less than or equal to 4.0 mg/dL.
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 |
|---|---|---|
| Flu-MelAlso: Fludara-Alkaran* Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL. * Melphalan will be administered following the completion of Fludarabine infusion at day -2. | Drug | Flu-Mel |
Primary outcome
To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM)
Time frame: 9years
-To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) following allogeneic nonmyeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen in patients with chronic lymphocytic leukemia (CLL), lymphoma, and multiple myeloma.
1 secondary outcome
include tumor response, incidence of chronic GVHD, and immune reconstitution.
Time frame: 9years
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 17 Feb 2011.
- Derived from this study: PubMed 26428486Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Lee KH. A Phase II Trial of Fludarabine/Melphalan 100 Conditioning Therapy Followed by Allogeneic Hematopoietic Cell Transplantation for Patients With Lymphoma. Clin Lymphoma Myeloma Leuk. 2015 Nov;15(11):655-63. doi: 10.1016/j.clml.2015.08.087. Epub 2015 Sep 3.
- Flu-MelLink 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.
Je-Hwan Lee, Doctor principal investigator
COSAH
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 Flu-Mel in people with Chronic Lymphocytic Leukemia and Lymphoma, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
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 5 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 17 Feb 2011. 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 South Korea. 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?
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?
To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) (time frame: 9years). 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 NCT00772811, 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 17 Feb 2011.