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Trial record 1 of 1 for:    AALL07P1
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Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00873093
First received: March 31, 2009
Last updated: November 30, 2016
Last verified: November 2016
Results First Received: February 9, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Lymphoblastic Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Interventions: Drug: L-asparaginase
Drug: doxorubicin hydrochloride
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Drug: cytarabine
Drug: prednisone
Drug: bortezomib
Drug: pegaspargase
Drug: methotrexate
Drug: etoposide phosphate
Drug: cyclophosphamide
Biological: filgrastim
Drug: leucovorin calcium
Other: laboratory biomarker analysis
Drug: High Dose MTX

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.

Participant Flow:   Overall Study
    Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr   Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr   Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs   T-cell ALL (Chemotherapy)   T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
STARTED   4   62   49   23   10 
COMPLETED   3   35   33   12   8 
NOT COMPLETED   1   27   16   11   2 
Adverse Event                0                2                0                0                0 
Death                0                3                2                0                0 
Physician Decision                0                17                10                10                2 
Withdrawal by Subject                1                4                4                0                0 
Ineligible                0                1                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Total Total of all reporting groups

Baseline Measures
   Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs   Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs   Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs   T-cell ALL (Chemotherapy)   T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   62   49   23   10   148 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      0   0.0%      53  85.5%      45  91.8%      20  87.0%      8  80.0%      126  85.1% 
Between 18 and 65 years      4 100.0%      9  14.5%      4   8.2%      3  13.0%      2  20.0%      22  14.9% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.14  (0.57)   10.16  (5.77)   9.27  (6.06)   13.00  (5.28)   13.79  (6.27)   10.91  (6.23) 
Gender 
[Units: Participants]
Count of Participants
           
Female      2  50.0%      29  46.8%      21  42.9%      6  26.1%      5  50.0%      63  42.6% 
Male      2  50.0%      33  53.2%      28  57.1%      17  73.9%      5  50.0%      85  57.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      1  25.0%      15  24.2%      18  36.7%      4  17.4%      0   0.0%      38  25.7% 
Not Hispanic or Latino      3  75.0%      44  71.0%      31  63.3%      19  82.6%      10 100.0%      107  72.3% 
Unknown or Not Reported      0   0.0%      3   4.8%      0   0.0%      0   0.0%      0   0.0%      3   2.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      1   1.6%      1   2.0%      1   4.3%      0   0.0%      3   2.0% 
Asian      0   0.0%      3   4.8%      1   2.0%      1   4.3%      0   0.0%      5   3.4% 
Native Hawaiian or Other Pacific Islander      1  25.0%      0   0.0%      0   0.0%      0   0.0%      1  10.0%      2   1.4% 
Black or African American      0   0.0%      9  14.5%      8  16.3%      4  17.4%      1  10.0%      22  14.9% 
White      2  50.0%      44  71.0%      34  69.4%      16  69.6%      8  80.0%      104  70.3% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1  25.0%      5   8.1%      5  10.2%      1   4.3%      0   0.0%      12   8.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy   [ Time Frame: The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy. ]

2.  Primary:   Event Free Survival   [ Time Frame: 4 months after enrollment ]

3.  Primary:   Toxic Death Rate   [ Time Frame: 4 months ]

4.  Primary:   Severe Adverse Events (SAE) Rate.   [ Time Frame: 4 months ]

5.  Secondary:   Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1   [ Time Frame: End of Block 1 (Day 36 of Block 1) of re-induction therapy ]

6.  Secondary:   Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2   [ Time Frame: End of Block 2 (Day 36 of Block 2) of re-induction therapy ]

7.  Secondary:   Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3   [ Time Frame: End of Block 3 (Day 36 of Block 3) of re-induction therapy ]

8.  Other Pre-specified:   NF-kB Activity   [ Time Frame: Up to 5 years ]

9.  Other Pre-specified:   Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots   [ Time Frame: Up to 5 years ]

10.  Other Pre-specified:   Change in Stem Cell Percentage   [ Time Frame: Baseline to post-treatment with bortezomib ]

11.  Other Pre-specified:   Plasma Concentration-time Profiles   [ Time Frame: Up to day 8 of block 2 ]

12.  Other Pre-specified:   Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.   [ Time Frame: Day 8 of blocks 1 and 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00873093     History of Changes
Other Study ID Numbers: NCI-2011-01908
NCI-2011-01908 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AALL07P1 ( Other Identifier: Children's Oncology Group )
AALL07P1 ( Other Identifier: CTEP )
U10CA180886 ( US NIH Grant/Contract Award Number )
U10CA098543 ( US NIH Grant/Contract Award Number )
Study First Received: March 31, 2009
Results First Received: February 9, 2016
Last Updated: November 30, 2016