Acute Myeloid LeukemiaPhase 4FLATNCT00488709
Fludarabine, Cytarabine, Topotecan in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 4 study testing Topotecan, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia, run by PETHEMA Foundation at 16 sites in Spain.
Trial summary
The study is designed with drugs used frequently in the treatment of AML, but with a new combination less toxic,and effective in AML multidrug resistant. Justification: The AML patients with primary resistance or relapsed in the first 12 months after CR, have second line chemotherapy low response rate . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Topotecan, Fludarabine and Cytarabine
- How many people
- 47 participants
- Where
- 16 sitesSpain
- Study dates
- May 2003to Apr 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of 18 years of age or major, with diagnosis of primary or secondary AML, confirmed cytologically, that fulfill one of the following conditions:
- Do not reach a CR after the conventional treatment.
- Relapse in the first 12 months after a CR. During remission, patients can have be treated by a transplant. The relapse is defined as the presence of blasts in peripheric blood or the presence of >5 % of blasts in MO.
- Not participation in a clinical trial.
- ECOG < o = 2
- Considered suitable patients for an intensive chemotherapy
- Informed consent
Who cannot join
- Pelvic or spinal radiotherapy in 4 weeks before the incorporation in the protocol.
- Acute promyelocytic leukaemia
- First line chemotherapy for AML which has contained fludarabine or topotecan.
- Active or chronic hepatitis or hepatic cirrhosis.
- Positivity known to the virus of the human immunodeficiency (HIV)
- Pregnant or breastfeeding patients.
Show all 18Show fewer
- Patients with deterioration of the functions hepatic or renal, defined for the following values base them of laboratory:
- AST or ALT >2,5 times the top limit of the normality of the center (LSNC)
- Alkaline phosphatase >2,5 times the LSNC
- Total bilirubin value >2 times the LSNC
- Creatinine value >2 times the LSNC after a suitable hydration
- Precedents of intervention of major surgery in 2 weeks before the incorporation in the protocol.
- Patients with disease serious or not controlled (for example not controlled diabetes, infection, hypertension, etc.).
- Patients who have received other cytotoxic drugs (except hydroxyurea to reduce the leucocytosis) as treatment of the current relapse or of the resistance, in 4 weeks before the protocol.
- Patients with hypersensitivity known to someone of the drugs of the protocol.
- Patients treated previously with growth factors with purposes of sensibilization.
- Patients with psychological, intellectual or sensitive dysfunction that can reduce his capacity of comprehension and fulfillment of the protocol.
- Patients treated before with FLAT.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Hospital Juan Canalejo
A Coruña
Hospital Ntra. Sra. de Sonsoles
Ávila
Hospital germans Trias i Pujol
Badalona
Centro Médico Teknon
Barcelona
Hospital Sant Pau
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital General Yagüe
Burgos
Hospital de Jerez
Cadiz
Complejo hospitalario Xeral-Calde
Lugo
Hospital Clínico Universitario San Carlos
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Virgen de la Victoria
Málaga
Hosptal Joan XXIII
Tarragona
Hospital Verge de la Cinta
Tortosa
Hospital Rio Hortega
Valladolid
Hospital Clinico Lozano Blesa
Zaragoza
About this study
Official title: FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
The study is designed with drugs used frequently in the treatment of AML, but with a new combination less toxic,and effective in AML multidrug resistant.
Justification:
- The AML patients with primary resistance or relapsed in the first 12 months after CR, have second line chemotherapy low response rate .
- These patients with AML with primary resistance or relapse, that reach remission after a rescue treatment, have an interval free survival and a global survival very short
- Probably the resistance to the treatments is in relation to different forms expression of the MDR.
- Complete remission is considered valid evaluation, because every patient who should obtain a CR can be considered to be eligible for a possible curative treatment: Ara-C administration to high doses or the TPH treatment
Read the detailed description
It is a protocol opened, multicentric, led to end to increase a) the rate of complete responses, b) the duration of the response, c) the free survival of disease and d) the global survival.
The included subjects will be patients with primary or secondary AML that they have not achieved the CR after the standard treatment with an anthracycline or derivative associated with Ara-C or have relapsed in the first 12 months after having achieved the RC. Also patients with AML that, for any reason, they could not receive the standard treatment with anthracycline and Ara-C, will be included
Cycle of induction. The patients will be treated by FLAT according to the following scheme:
- FLUDARABINE, 30 mg/m2 i.v. (In 1 hour) on the 1st to 4.
- CITARABINE, 2 g/m2 i.v. (In 4 hours), four hours after finishing the fludarabine, on the 1st to 4.
- TOPOTECAN, 1,5 mg/m2 i.v. (In 4 hours), four hours after finishing the cytarabine, on the 1st to 4.
When the patient starts recovering the hematological counts, and providing that has not blasts in the peripheral blood (SP), he will become a medullar revision (MO):
- If MO presents severe hypocellularity without blasts,no therapeutic measurement will take and there will repeat revisions weekly and MDR's study up to the CR or the blasts appearance.
- If in MO persist blasts (>5 %) but have diminished less than 50 % of the initial number, the induction will be continued by the FLAT's second shift.
- If in MO persists more than 50 % of blasts of the initial number, the patient goes out of the protocol and it will be treated as an agreement by the criterion of the center.
The patients who have managed to enter CR will receive a cycle of consolidation as soon as possible and always within 2 months from the day in which they received first FLAT's dose. The cycle of consolidation consists of another FLAT's scheme to the same doses.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Topotecan, Fludarabine, Cytarabine
- Keywords
- Acute Myeloid Leukemia, Multi Drug Resistance
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
FludarabineDrug
CytarabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To treat with the combination FLAT patients with acute myeloid leukaemia that they present a primary resistance
Measured: one month
•To treat with the combination FLAT a relapse in the first 12 months after reach the first CR with standard treatment
Measured: one month
To treat with combination FLAT patients can't receive the standard treatment due any cause
Measured: one month
Secondary outcomes (3)
Improve the interval free survival and global survival
Measured: one year
To avoid the toxicities produced by other chemotherapy in this type of patients
Measured: 4 months
To determine the existing association between the response to the treatment with FLAT and the expression of Multi Drug Resistance (MDR) in the acute myeloid leukaemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startMay 2003
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Bueno Javier, Dr, Study chair, Hospital Vall d'HebronSanchez Eva, Dr, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488709
- Sponsor's protocol ID
- LAMR 2003
- Other IDs
- FLAT
- Acronym
- FLAT
- Status last verified
- Nov 2008
- First submitted
- 1 Jun 2007
- Last updated
- 18 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bishop JF. The treatment of adult acute myeloid leukemia. Semin Oncol. 1997 Feb;24(1):57-69.
PubMed 9045305Stone RM. Treatment of acute myeloid leukemia: state-of-the-art and future directions. Semin Hematol. 2002 Jul;39(3 Suppl 2):4-10. doi: 10.1053/shem.2002.35977.
PubMed 12214287Lister TA, Rohatiner AZ. The treatment of acute myelogenous leukemia in adults. Semin Hematol. 1982 Jul;19(3):172-92.
PubMed 7051288Cassileth PA, Harrington DP, Appelbaum FR, Lazarus HM, Rowe JM, Paietta E, Willman C, Hurd DD, Bennett JM, Blume KG, Head DR, Wiernik PH. Chemotherapy compared with autologous or allogeneic bone marrow transplantation in the management of acute myeloid leukemia in first remission. N Engl J Med. 1998 Dec 3;339(23):1649-56. doi: 10.1056/NEJM199812033392301.
PubMed 9834301Rees JK, Gray RG, Swirsky D, Hayhoe FG. Principal results of the Medical Research Council's 8th acute myeloid leukaemia trial. Lancet. 1986 Nov 29;2(8518):1236-41. doi: 10.1016/s0140-6736(86)92674-7.
PubMed 2878130Vey N, Keating M, Giles F, Cortes J, Beran M, Estey E. Effect of complete remission on survival in patients with acute myelogenous leukemia receiving first salvage therapy. Blood. 1999 May 1;93(9):3149-50. No abstract available.
PubMed 10336269Del Poeta G, Venditti A, Aronica G, Stasi R, Cox MC, Buccisano F, Bruno A, Tamburini A, Suppo G, Simone MD, Epiceno AM, Del Moro B, Masi M, Papa G, Amadori S. P-glycoprotein expression in de novo acute myeloid leukemia. Leuk Lymphoma. 1997 Oct;27(3-4):257-74. doi: 10.3109/10428199709059682.
PubMed 9402325Germann UA. P-glycoprotein--a mediator of multidrug resistance in tumour cells. Eur J Cancer. 1996 Jun;32A(6):927-44. doi: 10.1016/0959-8049(96)00057-3. No abstract available.
PubMed 8763334Keating MJ, Kantarjian H, Smith TL, Estey E, Walters R, Andersson B, Beran M, McCredie KB, Freireich EJ. Response to salvage therapy and survival after relapse in acute myelogenous leukemia. J Clin Oncol. 1989 Aug;7(8):1071-80. doi: 10.1200/JCO.1989.7.8.1071.
PubMed 2666590Nussler V, Pelka-Fleischer R, Zwierzina H, Nerl C, Beckert B, Gieseler F, Diem H, Ledderose G, Gullis E, Sauer H, Wilmanns W. P-glycoprotein expression in patients with acute leukemia-clinical relevance. Leukemia. 1996 Jul;10 Suppl 3:S23-S31.
PubMed 8656697Hendricks CB, Rowinsky EK, Grochow LB, Donehower RC, Kaufmann SH. Effect of P-glycoprotein expression on the accumulation and cytotoxicity of topotecan (SK&F 104864), a new camptothecin analogue. Cancer Res. 1992 Apr 15;52(8):2268-78.
PubMed 1348448Michelutti A, Michieli M, Damiani D, Melli C, Ermacora A, Grimaz S, Candoni A, Russo D, Fanin R, Baccarani M. Effect of fludarabine and arabinosylcytosine on multidrug resistant cells. Haematologica. 1997 Mar-Apr;82(2):143-7.
PubMed 9175315Leoni F, Ciolli S, Nozzoli C, Santini V, Fanci R, Rossi Ferrini P. Fludarabine, cytarabine and topotecan (FLAT) as induction therapy for acute myeloid leukemia in the elderly: a preliminary report. Haematologica. 2001 Jan;86(1):104. No abstract available.
PubMed 11146581Frewin RJ, Johnson SA. The role of purine analogue combinations in the management of acute leukemias. Hematol Oncol. 2001 Dec;19(4):151-7. doi: 10.1002/hon.686.
PubMed 11754391Seiter K, Feldman EJ, Halicka HD, Traganos F, Darzynkiewicz Z, Lake D, Ahmed T. Phase I clinical and laboratory evaluation of topotecan and cytarabine in patients with acute leukemia. J Clin Oncol. 1997 Jan;15(1):44-51. doi: 10.1200/JCO.1997.15.1.44.
PubMed 8996123
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLAT: Fludarabine, Cytarabine and Topotecan in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00488709
- Acronym / sponsor ID
- FLAT / LAMR 2003
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Multi Drug Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Jun 2007 (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 study is designed with drugs used frequently in the treatment of AML, but with a new combination less toxic,and effective in AML multidrug resistant.
Justification:
- The AML patients with primary resistance or relapsed in the first 12 months after CR, have second line chemotherapy low response rate .
- These patients with AML with primary resistance or relapse, that reach remission after a rescue treatment, have an interval free survival and a global survival very short
- Probably the resistance to the treatments is in relation to different forms expression of the MDR.
- Complete remission is considered valid evaluation, because every patient who should obtain a CR can be considered to be eligible for a possible curative treatment: Ara-C administration to high doses or the TPH treatment
Detailed description
It is a protocol opened, multicentric, led to end to increase a) the rate of complete responses, b) the duration of the response, c) the free survival of disease and d) the global survival.
The included subjects will be patients with primary or secondary AML that they have not achieved the CR after the standard treatment with an anthracycline or derivative associated with Ara-C or have relapsed in the first 12 months after having achieved the RC. Also patients with AML that, for any reason, they could not receive the standard treatment with anthracycline and Ara-C, will be included
Cycle of induction. The patients will be treated by FLAT according to the following scheme:
- FLUDARABINE, 30 mg/m2 i.v. (In 1 hour) on the 1st to 4.
- CITARABINE, 2 g/m2 i.v. (In 4 hours), four hours after finishing the fludarabine, on the 1st to 4.
- TOPOTECAN, 1,5 mg/m2 i.v. (In 4 hours), four hours after finishing the cytarabine, on the 1st to 4.
When the patient starts recovering the hematological counts, and providing that has not blasts in the peripheral blood (SP), he will become a medullar revision (MO):
- If MO presents severe hypocellularity without blasts,no therapeutic measurement will take and there will repeat revisions weekly and MDR's study up to the CR or the blasts appearance.
- If in MO persist blasts (>5 %) but have diminished less than 50 % of the initial number, the induction will be continued by the FLAT's second shift.
- If in MO persists more than 50 % of blasts of the initial number, the patient goes out of the protocol and it will be treated as an agreement by the criterion of the center.
The patients who have managed to enter CR will receive a cycle of consolidation as soon as possible and always within 2 months from the day in which they received first FLAT's dose. The cycle of consolidation consists of another FLAT's scheme to the same doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects of 18 years of age or major, with diagnosis of primary or secondary AML, confirmed cytologically, that fulfill one of the following conditions:
- ECOG < o = 2
- Considered suitable patients for an intensive chemotherapy
- Informed consent
Key exclusion criteria (18 listed)
- Pelvic or spinal radiotherapy in 4 weeks before the incorporation in the protocol.
- Acute promyelocytic leukaemia
- First line chemotherapy for AML which has contained fludarabine or topotecan.
- Active or chronic hepatitis or hepatic cirrhosis.
- Positivity known to the virus of the human immunodeficiency (HIV)
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 |
|---|---|---|
| Topotecan | Drug | – |
| Fludarabine | Drug | – |
| Cytarabine | Drug | – |
Primary outcome
To treat with the combination FLAT patients with acute myeloid leukaemia that they present a primary resistance
Time frame: one month
•To treat with the combination FLAT a relapse in the first 12 months after reach the first CR with standard treatment
Time frame: one month
To treat with combination FLAT patients can't receive the standard treatment due any cause
Time frame: one month
3 secondary outcomes
Improve the interval free survival and global survival
Time frame: one year
To avoid the toxicities produced by other chemotherapy in this type of patients
Time frame: 4 months
To determine the existing association between the response to the treatment with FLAT and the expression of Multi Drug Resistance (MDR) in the acute myeloid leukaemia
Time frame: 6 months
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 18 Nov 2008.
- Background: PubMed 9045305Bishop JF. The treatment of adult acute myeloid leukemia. Semin Oncol. 1997 Feb;24(1):57-69.
- Background: PubMed 12214287Stone RM. Treatment of acute myeloid leukemia: state-of-the-art and future directions. Semin Hematol. 2002 Jul;39(3 Suppl 2):4-10. doi: 10.1053/shem.2002.35977.
- Background: PubMed 7051288Lister TA, Rohatiner AZ. The treatment of acute myelogenous leukemia in adults. Semin Hematol. 1982 Jul;19(3):172-92.
- Background: PubMed 9834301Cassileth PA, Harrington DP, Appelbaum FR, Lazarus HM, Rowe JM, Paietta E, Willman C, Hurd DD, Bennett JM, Blume KG, Head DR, Wiernik PH. Chemotherapy compared with autologous or allogeneic bone marrow transplantation in the management of acute myeloid leukemia in first remission. N Engl J Med. 1998 Dec 3;339(23):1649-56. doi: 10.1056/NEJM199812033392301.
- Background: PubMed 2878130Rees JK, Gray RG, Swirsky D, Hayhoe FG. Principal results of the Medical Research Council's 8th acute myeloid leukaemia trial. Lancet. 1986 Nov 29;2(8518):1236-41. doi: 10.1016/s0140-6736(86)92674-7.
- Background: PubMed 10336269Vey N, Keating M, Giles F, Cortes J, Beran M, Estey E. Effect of complete remission on survival in patients with acute myelogenous leukemia receiving first salvage therapy. Blood. 1999 May 1;93(9):3149-50. No abstract available.
- Background: PubMed 9402325Del Poeta G, Venditti A, Aronica G, Stasi R, Cox MC, Buccisano F, Bruno A, Tamburini A, Suppo G, Simone MD, Epiceno AM, Del Moro B, Masi M, Papa G, Amadori S. P-glycoprotein expression in de novo acute myeloid leukemia. Leuk Lymphoma. 1997 Oct;27(3-4):257-74. doi: 10.3109/10428199709059682.
- Background: PubMed 8763334Germann UA. P-glycoprotein--a mediator of multidrug resistance in tumour cells. Eur J Cancer. 1996 Jun;32A(6):927-44. doi: 10.1016/0959-8049(96)00057-3. No abstract available.
- Background: PubMed 2666590Keating MJ, Kantarjian H, Smith TL, Estey E, Walters R, Andersson B, Beran M, McCredie KB, Freireich EJ. Response to salvage therapy and survival after relapse in acute myelogenous leukemia. J Clin Oncol. 1989 Aug;7(8):1071-80. doi: 10.1200/JCO.1989.7.8.1071.
- Background: PubMed 8656697Nussler V, Pelka-Fleischer R, Zwierzina H, Nerl C, Beckert B, Gieseler F, Diem H, Ledderose G, Gullis E, Sauer H, Wilmanns W. P-glycoprotein expression in patients with acute leukemia-clinical relevance. Leukemia. 1996 Jul;10 Suppl 3:S23-S31.
- Background: PubMed 1348448Hendricks CB, Rowinsky EK, Grochow LB, Donehower RC, Kaufmann SH. Effect of P-glycoprotein expression on the accumulation and cytotoxicity of topotecan (SK&F 104864), a new camptothecin analogue. Cancer Res. 1992 Apr 15;52(8):2268-78.
- Background: PubMed 9175315Michelutti A, Michieli M, Damiani D, Melli C, Ermacora A, Grimaz S, Candoni A, Russo D, Fanin R, Baccarani M. Effect of fludarabine and arabinosylcytosine on multidrug resistant cells. Haematologica. 1997 Mar-Apr;82(2):143-7.
- Spanish association of HaematologyLink 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.
Bueno Javier, Dr study chair
Hospital Vall d'Hebron
Sanchez Eva, Dr principal investigator
Hospital Vall d'Hebron
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topotecan, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia, run by PETHEMA Foundation at 16 sites in Spain.
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 7 inclusion and 18 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 18 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 treat with the combination FLAT patients with acute myeloid leukaemia that they present a primary resistance (time frame: one month). The study lists 3 primary outcomes in all. 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 NCT00488709, which also lists 18 linked publications.
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 18 Nov 2008.